Sterile Specimen Container Suppliers
Limit companies to: Worldwide USA
DeRoyal Industries | Address: 200 DeBusk Lane, Powell, Tennessee 37849, USA 
www.deroyal.com | Send Inquiry | Phone: +1-(800)-251-9864
FDA Registration: 1048770 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Splints, Autoclaves, Forceps (FDA Code: HTD), Procedure Trays, Retractors, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable s more...
www.deroyal.com | Send Inquiry | Phone: +1-(800)-251-9864
FDA Registration: 1048770 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~30 Quality: ISO Certified
Products: Splints, Autoclaves, Forceps (FDA Code: HTD), Procedure Trays, Retractors, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
DeRoyal Industries manufactures healthcare products. Our product ranges from orthopedic hospital brands to online tools that power the medical industry. Our night splint is available with adjustable s more...
Parter Medical Products Inc. | Address: 17015 Kingsview Ave., Carson, California 90746, USA
partermedical.com | Send Inquiry | Phone: +1-(310)-327-4417, 800-666-8282
FDA Registration: 2024311 Year Established: 1984 Annual Revenues: USD 5-10 Million Employee Count: ~140 Quality: ISO 9002 Certified
Products: Plastic Vials, Laboratory Plasticware, Petri Dishes, Petri Dishes, Petri Dishes & Nutrient Agar Kit, Petri Dish Spreaders, Petri Dish Dispenser, ...
Parter Medical Products Inc. manufactures single use, plastic, laboratory products for healthcare, medical and pharmaceutical research markets. We offer petri dishes, specimen containers, and 24 hour more...
partermedical.com | Send Inquiry | Phone: +1-(310)-327-4417, 800-666-8282
FDA Registration: 2024311 Year Established: 1984 Annual Revenues: USD 5-10 Million Employee Count: ~140 Quality: ISO 9002 Certified
Products: Plastic Vials, Laboratory Plasticware, Petri Dishes, Petri Dishes, Petri Dishes & Nutrient Agar Kit, Petri Dish Spreaders, Petri Dish Dispenser, ...
Parter Medical Products Inc. manufactures single use, plastic, laboratory products for healthcare, medical and pharmaceutical research markets. We offer petri dishes, specimen containers, and 24 hour more...
Sandel Medical Industries, Llc | Address: 19736 Dearborn Street, Chatsworth, California 91311, USA
www.sandelmedical.com | Send Inquiry | Phone: +1-(866)-764-3327
FDA Registration: 3004125670 Quality: ISO 13485 Certified
Products: Scalpels, Chairs & stools, Foot Stools, Scalpel Handle (FDA Code: GDZ), Safety Scalpel System, Surgical Skin Markers (FDA Code: FZZ), ...
Sandel Medical Industries, Llc focuses on addressing and eliminating safety issues for patients and health care staff. Our products include engineered sharps injury prevention, ergonomic workplace saf more...
www.sandelmedical.com | Send Inquiry | Phone: +1-(866)-764-3327
FDA Registration: 3004125670 Quality: ISO 13485 Certified
Products: Scalpels, Chairs & stools, Foot Stools, Scalpel Handle (FDA Code: GDZ), Safety Scalpel System, Surgical Skin Markers (FDA Code: FZZ), ...
Sandel Medical Industries, Llc focuses on addressing and eliminating safety issues for patients and health care staff. Our products include engineered sharps injury prevention, ergonomic workplace saf more...
Croan Engineering Co. | Address: 5401 Business Dr., Huntington Beach, California 92649-1225, USA
Phone: +1-(714)-893-0561
Annual Revenues: < USD 1 Million Employee Count: ~20
Products: Non-Sterile Barrier Pipette Tips, Racked Non-Sterile Non-Barrier Pipette Tips, Sterile Barrier Pipette Tips, Sterile Non-Barrier Pipette Tips, Racked Non-Sterile Non-Barrier Multi-Channel Pipette Tips, Disposable Pipette Tips, Non-sterile Disposable Tips, ...
Croan Engineering Co. specializes in offering plastic injection molded products for the medical industries. Our products include blood collection systems, disposable basic labware, non-sterile disposa more...
Phone: +1-(714)-893-0561
Annual Revenues: < USD 1 Million Employee Count: ~20
Products: Non-Sterile Barrier Pipette Tips, Racked Non-Sterile Non-Barrier Pipette Tips, Sterile Barrier Pipette Tips, Sterile Non-Barrier Pipette Tips, Racked Non-Sterile Non-Barrier Multi-Channel Pipette Tips, Disposable Pipette Tips, Non-sterile Disposable Tips, ...
Croan Engineering Co. specializes in offering plastic injection molded products for the medical industries. Our products include blood collection systems, disposable basic labware, non-sterile disposa more...
Tagg Industries L.L.C. | Address: 23210 Del Lago, Laguna Hills, California 92653, USA
www.taggmed.com | Send Inquiry | Phone: +1-(949)-770-9029, 800-548-3514
Year Established: 1984 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: ISO, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Surgical Scissors, Ring Cutters (FDA Code: FNS), Splinter Forceps, Bandage Scissors, Mosquito Forceps, ...
Tagg Industries L.L.C. manufactures lock boxes, PTP masks in adult and child sizes, a one-way valve for masks & medical instruments. We are a distributor of medical supplies. We provide PTP® valve more...
www.taggmed.com | Send Inquiry | Phone: +1-(949)-770-9029, 800-548-3514
Year Established: 1984 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: ISO, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Surgical Scissors, Ring Cutters (FDA Code: FNS), Splinter Forceps, Bandage Scissors, Mosquito Forceps, ...
Tagg Industries L.L.C. manufactures lock boxes, PTP masks in adult and child sizes, a one-way valve for masks & medical instruments. We are a distributor of medical supplies. We provide PTP® valve more...
Bioseal Medical Packaging Concepts | Address: 167 W. Orangethrope Ave., Placentia, California 92870-6922, USA
www.biosealnet.com | Send Inquiry | Phone: +1-(714)-528-4695, 800-441-7325
FDA Registration: 2027062 Year Established: 1988 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO Certified
Products: General Orthopedic Supplies, Tubular Elastic Bandages & Nets, Elastic Bandages (FDA Code: FQM), Adhesive Elastic Bandage Tape, Self Adhesive Elastic Bandage, Cotton Balls, ...
Bioseal Medical Packaging Concepts delivers custom packaging and sterilization services for single-use items in the operating room & beyond. We provide critical services to the healthcare industry, su more...
www.biosealnet.com | Send Inquiry | Phone: +1-(714)-528-4695, 800-441-7325
FDA Registration: 2027062 Year Established: 1988 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO Certified
Products: General Orthopedic Supplies, Tubular Elastic Bandages & Nets, Elastic Bandages (FDA Code: FQM), Adhesive Elastic Bandage Tape, Self Adhesive Elastic Bandage, Cotton Balls, ...
Bioseal Medical Packaging Concepts delivers custom packaging and sterilization services for single-use items in the operating room & beyond. We provide critical services to the healthcare industry, su more...
Amsino International, Inc | Address: 855 Towne Center Drive, Pomona, California 91767, USA
www.amsino.com | Send Inquiry | Phone: +1-(906)-626-5888
FDA Registration: 2085175 Year Established: 1993 Annual Revenues: USD 25-50 Million Employee Count: ~500 Quality: ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Urine Collection Leg Bags (FDA Code: FAQ), IV Catheters & Infusion Sets, IV Sets, General EMT, ...
Amsino International, Inc is an ISO 9001 certified company. We manufacture disposable medical products. We specialize in urology, general feeding with irrigation, IV therapy products, surgical, genera more...
www.amsino.com | Send Inquiry | Phone: +1-(906)-626-5888
FDA Registration: 2085175 Year Established: 1993 Annual Revenues: USD 25-50 Million Employee Count: ~500 Quality: ISO 9001, CE Certified
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Urine Collection Leg Bags (FDA Code: FAQ), IV Catheters & Infusion Sets, IV Sets, General EMT, ...
Amsino International, Inc is an ISO 9001 certified company. We manufacture disposable medical products. We specialize in urology, general feeding with irrigation, IV therapy products, surgical, genera more...
ICU Medical, Inc | Address: 951 Calle Amanecer, San Clemente, California 92673, USA
www.icumed.com | Send Inquiry | Phone: +1-(949)-366-2183, 800-824-7890
FDA Registration: 1713468 Year Established: 1984 Employee Count: ~1700 Quality: ISO 9001, ISO 9002, CE Certified
Products: Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Volumetric Infusion Pumps, IV Fluids, IV Sets, General Sutures/Needles, ...
ICU Medical, Inc. deals with safety medical systems. Our antimicrobial clave provides at least a 4-log bacterial kill rate for a continuous 96-hour use life. This method of manufacturing eliminates th more...
www.icumed.com | Send Inquiry | Phone: +1-(949)-366-2183, 800-824-7890
FDA Registration: 1713468 Year Established: 1984 Employee Count: ~1700 Quality: ISO 9001, ISO 9002, CE Certified
Products: Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Volumetric Infusion Pumps, IV Fluids, IV Sets, General Sutures/Needles, ...
ICU Medical, Inc. deals with safety medical systems. Our antimicrobial clave provides at least a 4-log bacterial kill rate for a continuous 96-hour use life. This method of manufacturing eliminates th more...
McKesson Corporation | Address: One Post Street, San Francisco, California 94104, USA
www.mckesson.com | Send Inquiry | Phone: +1-(415)-983-8300
Year Established: 1997 Annual Revenues: USD 5-10 Million Employee Count: ~350
Products: Consulting Services, Contract Manufacturers, Blood Gas Capillary Tubes, Analgesics, Anesthetics, Antibiotics, ...
McKesson Corporation provides information and care management products & services that are designed to reduce costs & improve quality across healthcare. We specialize in pharmaceutical distribution an more...
www.mckesson.com | Send Inquiry | Phone: +1-(415)-983-8300
Year Established: 1997 Annual Revenues: USD 5-10 Million Employee Count: ~350
Products: Consulting Services, Contract Manufacturers, Blood Gas Capillary Tubes, Analgesics, Anesthetics, Antibiotics, ...
McKesson Corporation provides information and care management products & services that are designed to reduce costs & improve quality across healthcare. We specialize in pharmaceutical distribution an more...
Diagnostics For The Real World, Ltd. | Address: 840 Del Rey Avenue, Sunnyvale, California 94085-2919, USA
Phone: +1-(408)-773-1511
FDA Registration: 3006247421
Products: Chlamydia Group Enzyme Linked Immunoabsorbent Assay (FDA Code: LJC), Sterile Specimen Container (FDA Code: FMH), ...
Diagnostics For The Real World, Ltd. manufactures sterile specimen containers. more...
Phone: +1-(408)-773-1511
FDA Registration: 3006247421
Products: Chlamydia Group Enzyme Linked Immunoabsorbent Assay (FDA Code: LJC), Sterile Specimen Container (FDA Code: FMH), ...
Diagnostics For The Real World, Ltd. manufactures sterile specimen containers. more...
Medtronic Spine LLC | Address: 1221 Crossman Ave., Sunnyvale, California 94089, USA
www.medtronicspine.com | Send Inquiry | Phone: +1-(408)-548-6500, 877-690-5353
FDA Registration: 2953769 Year Established: 1994
Products: Forceps (FDA Code: HTD), Drill Bit (FDA Code: HTW), Tamps (FDA Code: HXG), Drill Bits & Bone Taps, Cannulated Drill Bit, Anesthetic Conduction Needle with/without Introducer (FDA Code: BSP), ...
Medtronic Spine LLC offers online resource for neck pain, back pain, spinal health and treatment options for the same. Our cervical products for spinal surgery include plates, tissues and interbodies more...
www.medtronicspine.com | Send Inquiry | Phone: +1-(408)-548-6500, 877-690-5353
FDA Registration: 2953769 Year Established: 1994
Products: Forceps (FDA Code: HTD), Drill Bit (FDA Code: HTW), Tamps (FDA Code: HXG), Drill Bits & Bone Taps, Cannulated Drill Bit, Anesthetic Conduction Needle with/without Introducer (FDA Code: BSP), ...
Medtronic Spine LLC offers online resource for neck pain, back pain, spinal health and treatment options for the same. Our cervical products for spinal surgery include plates, tissues and interbodies more...
Garren Scientific, Inc. | Address: 15916 Blythe St., Unit A, Van Nuys, California 91406, USA
Phone: +1-(818)-989-6340, 800-342-3725
Year Established: 1982 Annual Revenues: USD 1-5 Million
Products: Blood Collection Needles, Microscope Slide Staining Kit, Automated Urinalysis System (FDA Code: KQO), Microscope Slide Dispenser, Laboratory Plasticware, Centrifuge Tubes, Hinged Culture Tube Storage boxes, ...
Garren Scientific, Inc. is a provider of scientific and laboratory equipments. We offer automated urinalysis system, blood collection needles, blood diluting pipettes, culture tubes, double-ended bloo more...
Phone: +1-(818)-989-6340, 800-342-3725
Year Established: 1982 Annual Revenues: USD 1-5 Million
Products: Blood Collection Needles, Microscope Slide Staining Kit, Automated Urinalysis System (FDA Code: KQO), Microscope Slide Dispenser, Laboratory Plasticware, Centrifuge Tubes, Hinged Culture Tube Storage boxes, ...
Garren Scientific, Inc. is a provider of scientific and laboratory equipments. We offer automated urinalysis system, blood collection needles, blood diluting pipettes, culture tubes, double-ended bloo more...
Beekley Corp | Address: One Prestige Lane, Bristol, Connecticut 06010, USA
www.beekley.com | Send Inquiry | Phone: +1-(800)-2335539
Quality: ISO 13485:2003 Certified
Products: Computed Tomography, Adhesive Bandages (FDA Code: KGX), Medical Imaging, Mammography Devices, Positioning System Accessories, Computed Tomography Accessories, ...
Beekley Corp distributes medical imaging equipment. Our pointguards protect longer, more linear temporary marks during radiation therapy treatment. Our self adhesive CT guidelines biopsy grid is used more...
www.beekley.com | Send Inquiry | Phone: +1-(800)-2335539
Quality: ISO 13485:2003 Certified
Products: Computed Tomography, Adhesive Bandages (FDA Code: KGX), Medical Imaging, Mammography Devices, Positioning System Accessories, Computed Tomography Accessories, ...
Beekley Corp distributes medical imaging equipment. Our pointguards protect longer, more linear temporary marks during radiation therapy treatment. Our self adhesive CT guidelines biopsy grid is used more...
Rece International Corp. | Address: 5881 N.W. 151st St., Ste. 111, Miami Lakes, Florida 33014, USA
Phone: +1-(305)-3626555
FDA Registration: 3003965134
Products: Oxygen Masks (FDA Code: BYG), Gastroenterologic Needle Holder (FDA Code: FHQ), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Infusion Catheter (FDA Code: JCY), Elastic Bandages (FDA Code: FQM), ...
Rece International Corp. provides surgical and medical equipments such as adult tongue depressors, blood collection lancets, elastic stockings, emesis basins, hydrophilic wound dressings, venturi low more...
Phone: +1-(305)-3626555
FDA Registration: 3003965134
Products: Oxygen Masks (FDA Code: BYG), Gastroenterologic Needle Holder (FDA Code: FHQ), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Infusion Catheter (FDA Code: JCY), Elastic Bandages (FDA Code: FQM), ...
Rece International Corp. provides surgical and medical equipments such as adult tongue depressors, blood collection lancets, elastic stockings, emesis basins, hydrophilic wound dressings, venturi low more...
Genicon | Address: 6869 Stapoint Court, Suite #114, Winter Park, Florida 32792, USA
www.geniconendo.com | Send Inquiry | Phone: +1-(407)-657-4851, 800-936-1020
FDA Registration: 1064003 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 13485:2003 Certified
Products: Graspers, Straight Scissors, Bladeless Trocars, Sterilization Tray, Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), General & Plastic Surgery Laparoscope (FDA Code: GCJ), ...
Genicon deals with the design, production, and distribution of patented surgical instrumentation focused exclusively on laparoscopic surgery. Our product line includes several families of laparoscopic more...
www.geniconendo.com | Send Inquiry | Phone: +1-(407)-657-4851, 800-936-1020
FDA Registration: 1064003 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO 13485:2003 Certified
Products: Graspers, Straight Scissors, Bladeless Trocars, Sterilization Tray, Electrosurgical Cutting and Coagulation Device (FDA Code: GEI), General & Plastic Surgery Laparoscope (FDA Code: GCJ), ...
Genicon deals with the design, production, and distribution of patented surgical instrumentation focused exclusively on laparoscopic surgery. Our product line includes several families of laparoscopic more...
C. R. Bard, Inc., Bard Medical Div. | Address: 8195 Industrial Blvd., Covington, Georgia 30209, USA
www.bardmedical.com | Send Inquiry | Phone: +1-(770)-784-6100, 800-526-4455
FDA Registration: 3006082230 Quality: ISO 9001 Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Catheter Introducers (FDA Code: DYB), Arthroscopes (FDA Code: HRX), Electrode Cables (FDA Code: IKD), Urethral Catheters (FDA Code: GBM), Urine Collection Leg Bags (FDA Code: FAQ), ...
C. R. Bard, Inc., Bard Medical Div. provides products and services that meet the needs of healthcare providers & patients. We specialize in disease state management offering the industry's comprehensi more...
www.bardmedical.com | Send Inquiry | Phone: +1-(770)-784-6100, 800-526-4455
FDA Registration: 3006082230 Quality: ISO 9001 Certified
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Catheter Introducers (FDA Code: DYB), Arthroscopes (FDA Code: HRX), Electrode Cables (FDA Code: IKD), Urethral Catheters (FDA Code: GBM), Urine Collection Leg Bags (FDA Code: FAQ), ...
C. R. Bard, Inc., Bard Medical Div. provides products and services that meet the needs of healthcare providers & patients. We specialize in disease state management offering the industry's comprehensi more...
Sonoco | Address: 3150 Clinton Ct., Norcross, Georgia 30071, USA
www.sonoco.com | Send Inquiry | Phone: +1-(770)-476-9088
Year Established: 1899 Annual Revenues: < USD 1 Million Employee Count: ~50 Quality: ISO 9000, ISO 9002, CE Certified
Products: Test Tubes, Pouches, Cartridges, Cuvette, Disposable Basic Labware, Sterile Specimen Container (FDA Code: FMH), ...
Sonoco deals with molded & extruded plastics and paperboard specialties. Our custom printed Stancap® glass covers, Rixie™ coasters and other paper amenities are used in healthcare facilities more...
www.sonoco.com | Send Inquiry | Phone: +1-(770)-476-9088
Year Established: 1899 Annual Revenues: < USD 1 Million Employee Count: ~50 Quality: ISO 9000, ISO 9002, CE Certified
Products: Test Tubes, Pouches, Cartridges, Cuvette, Disposable Basic Labware, Sterile Specimen Container (FDA Code: FMH), ...
Sonoco deals with molded & extruded plastics and paperboard specialties. Our custom printed Stancap® glass covers, Rixie™ coasters and other paper amenities are used in healthcare facilities more...
Thermosafe Brands | Address: 3930 Ventura Drive, Suite 450, Arlington Heights, Illinois 60004, USA
www.thermosafe.com | Send Inquiry | Phone: +1-(847)-398-0110, 800-323-7442
Year Established: 1946 Annual Revenues: USD 50-100 Million Employee Count: ~500 Quality: ISO 9001 Certified
Products: Heat or Cold Packs, Hot & Cold Therapy Products, Cold Pack Wraps, Hot & Cold Therapy Products, Cold Pack Freezer, Hot & Cold Therapy Products, Inflatable Cold Packs, Non-ice Cold Packs, Reusable Hot & Cold Packs, ...
ThermoSafe Brands, a strategic business unit Tegrant Corporation is a provider of temperature assurance products and testing services. We offer packaging components and thermal engineering & testing s more...
www.thermosafe.com | Send Inquiry | Phone: +1-(847)-398-0110, 800-323-7442
Year Established: 1946 Annual Revenues: USD 50-100 Million Employee Count: ~500 Quality: ISO 9001 Certified
Products: Heat or Cold Packs, Hot & Cold Therapy Products, Cold Pack Wraps, Hot & Cold Therapy Products, Cold Pack Freezer, Hot & Cold Therapy Products, Inflatable Cold Packs, Non-ice Cold Packs, Reusable Hot & Cold Packs, ...
ThermoSafe Brands, a strategic business unit Tegrant Corporation is a provider of temperature assurance products and testing services. We offer packaging components and thermal engineering & testing s more...
LSL Industries Inc. | Address: 5535 N Wolcott Ave, Chicago, Illinois 60640-1019, USA
www.lslhealthcare.com | Send Inquiry | Phone: +1-(773)-878-1100
FDA Registration: 1420054 Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~40 Quality: ISO Certified
Products: General Medical Supplies, Suturing Kits & Removal Kits, Central Venous Catheters, Adhesive Bandages (FDA Code: KGX), Suture Removal Kit (FDA Code: MCZ), Fracture Bedpans, ...
LSL Industries Inc. offers a wide variety of disposable medical devices, component parts, various hospital supplies, disposable kits and surgical procedure kits. We also offer drainage bags, preconnec more...
www.lslhealthcare.com | Send Inquiry | Phone: +1-(773)-878-1100
FDA Registration: 1420054 Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~40 Quality: ISO Certified
Products: General Medical Supplies, Suturing Kits & Removal Kits, Central Venous Catheters, Adhesive Bandages (FDA Code: KGX), Suture Removal Kit (FDA Code: MCZ), Fracture Bedpans, ...
LSL Industries Inc. offers a wide variety of disposable medical devices, component parts, various hospital supplies, disposable kits and surgical procedure kits. We also offer drainage bags, preconnec more...
Freund Container | Address: Corporate Center II, 4200 Commerce Court Suite 206, Lisle, Illinois 60532, USA
www.freundcontainer.com | Send Inquiry | Phone: +1-(708)-272-7099, 800-363-9822
Annual Revenues: USD 10-25 Million Employee Count: ~40
Products: Glove Boxes, Glass & Plastic Bottles, Disposable Gloves, Exam Gloves, Glass Medical Jars, Laboratory Plasticware, Bottles, ...
Freund Container is a provider of plastic, metal and glass containers. Our products include glass bottles & jars, plastic bottles, closures, container labels, metal cans, material handling and safety more...
www.freundcontainer.com | Send Inquiry | Phone: +1-(708)-272-7099, 800-363-9822
Annual Revenues: USD 10-25 Million Employee Count: ~40
Products: Glove Boxes, Glass & Plastic Bottles, Disposable Gloves, Exam Gloves, Glass Medical Jars, Laboratory Plasticware, Bottles, ...
Freund Container is a provider of plastic, metal and glass containers. Our products include glass bottles & jars, plastic bottles, closures, container labels, metal cans, material handling and safety more...
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FDA Code / Regulation: FMH / 864.3250
A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 864.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180 of this chapter, with respect to general requirements concerning records, and 820.198 of this chapter, with respect to complaint files.
