Microscope Slide Coverslip Suppliers
Limit companies to: Worldwide USA
Remel | Address: 12076 Santa Fe Drive, P.O. Box 14428, Lenexa, Kansas 66215, USA 
www.remelinc.com | Send Inquiry | Phone: +1-(913)-888-0939
FDA Registration: 1031428 Year Established: 1973 Employee Count: ~20
Products: Pregnancy Kits, Cotton Swabs, Home pregnancy test kits, Hcg, Early Pregnancy Testing Kit, Sensitive Pregnancy Tests, Diagnostic Test Kits For Pregnancy, ...
Remel offers a wide range of microbiology products that are used in the clinical, industrial, research and academic laboratories. Our products help diagnose infection quickly and accurately, providing more...
www.remelinc.com | Send Inquiry | Phone: +1-(913)-888-0939
FDA Registration: 1031428 Year Established: 1973 Employee Count: ~20
Products: Pregnancy Kits, Cotton Swabs, Home pregnancy test kits, Hcg, Early Pregnancy Testing Kit, Sensitive Pregnancy Tests, Diagnostic Test Kits For Pregnancy, ...
Remel offers a wide range of microbiology products that are used in the clinical, industrial, research and academic laboratories. Our products help diagnose infection quickly and accurately, providing more...
Corning Incorporated | Address: Tower 2, 4th Floor, 900 Chelmsford Street, Lowell, Massachusetts 01851, USA
www.corning.com | Send Inquiry | Phone: +1-(978)-442-2200
FDA Registration: 1054657 Annual Revenues: USD 100-500 Million Employee Count: ~20000 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: General Diagnostic Supplies, General Examination Supplies, Pipettors, Pipettes, Disposable Pipette Tips, Non-sterile Disposable Tips, Adjustable-Volume Pipettors, Electronic Pipettes, ...
Corning Incorporated Life Sciences is a diversified technology company. We concentrate on high-impact growth opportunities in the telecommunications, flat panel display, environmental, life sciences a more...
www.corning.com | Send Inquiry | Phone: +1-(978)-442-2200
FDA Registration: 1054657 Annual Revenues: USD 100-500 Million Employee Count: ~20000 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: General Diagnostic Supplies, General Examination Supplies, Pipettors, Pipettes, Disposable Pipette Tips, Non-sterile Disposable Tips, Adjustable-Volume Pipettors, Electronic Pipettes, ...
Corning Incorporated Life Sciences is a diversified technology company. We concentrate on high-impact growth opportunities in the telecommunications, flat panel display, environmental, life sciences a more...
Kimble Chase Life Science and Research Products LLC | Address: 1022 Spruce Street, Vineland, Minnesota 08360, USA
www.kimble-chase.com | Send Inquiry | Phone: +1-(856)-692-8500
Year Established: 1901 Annual Revenues: USD 50-100 Million Employee Count: ~770 Quality: ISO 9001, ISO 9002 Certified
Products: General Medical Supplies, General Diagnostics, General Examination Supplies, Pipettors, Pipettes, Test Tubes, Rimmed Glass Test Tubes, ...
Kimble Chase Life Science and Research Products LLC distributes a full range of reusable, disposable & specialty laboratory glassware for pharmaceutical, chromatography, environmental, petrochemical, more...
www.kimble-chase.com | Send Inquiry | Phone: +1-(856)-692-8500
Year Established: 1901 Annual Revenues: USD 50-100 Million Employee Count: ~770 Quality: ISO 9001, ISO 9002 Certified
Products: General Medical Supplies, General Diagnostics, General Examination Supplies, Pipettors, Pipettes, Test Tubes, Rimmed Glass Test Tubes, ...
Kimble Chase Life Science and Research Products LLC distributes a full range of reusable, disposable & specialty laboratory glassware for pharmaceutical, chromatography, environmental, petrochemical, more...
Fisher Scientific International, Inc. | Address: Liberty Lane, Hampton, New Hampshire 03842, USA
www.fisherscientific.com | Send Inquiry | Phone: +1-(603)-926-5911
FDA Registration: 2431530 Annual Revenues: USD 50-100 Million Employee Count: ~3300
Products: Slide Staining, General Medical Supplies, General Examination Supplies, Manual Slide Staining System, Microscope Slide Staining Kit, EasyDip Slide Staining, ...
Fisher Scientific International, Inc. provides products & services to the scientific research community & clinical laboratories. We manufacture and distribute a wide array of diagnostic kits & reagent more...
www.fisherscientific.com | Send Inquiry | Phone: +1-(603)-926-5911
FDA Registration: 2431530 Annual Revenues: USD 50-100 Million Employee Count: ~3300
Products: Slide Staining, General Medical Supplies, General Examination Supplies, Manual Slide Staining System, Microscope Slide Staining Kit, EasyDip Slide Staining, ...
Fisher Scientific International, Inc. provides products & services to the scientific research community & clinical laboratories. We manufacture and distribute a wide array of diagnostic kits & reagent more...
Bellco Glass, Inc. | Address: 340 Edrudo Road, Vineland, New Jersey 08360, USA
www.bellcoglass.com | Send Inquiry | Phone: +1-(856)-691-1075, 800-257-7043
Annual Revenues: USD 10-25 Million Quality: ISO 9001, CE Certified
Products: Incubator Shakers, Incubator shakers (orbital), Stackable Incubator Shakers, Orbital Incubator Shakers, Laboratory Plasticware, Beakers, Graduated Glass Cylinder, ...
Bellco Glass, Inc. designs and fabricates laboratory glassware & equipment. Our products include bioreactors, labware, plastic, corning, benchtop equipment, and spinner flasks. Our BelloCell® is a more...
www.bellcoglass.com | Send Inquiry | Phone: +1-(856)-691-1075, 800-257-7043
Annual Revenues: USD 10-25 Million Quality: ISO 9001, CE Certified
Products: Incubator Shakers, Incubator shakers (orbital), Stackable Incubator Shakers, Orbital Incubator Shakers, Laboratory Plasticware, Beakers, Graduated Glass Cylinder, ...
Bellco Glass, Inc. designs and fabricates laboratory glassware & equipment. Our products include bioreactors, labware, plastic, corning, benchtop equipment, and spinner flasks. Our BelloCell® is a more...
Propper Manufacturing Co. Inc. | Address: 36-04 Skillman Avenue, Long Island City, New York 11101, USA
www.proppermfg.com | Send Inquiry | Phone: +1-(800)-832-4300
FDA Registration: 2410251 Year Established: 1935 Annual Revenues: USD 25-50 Million Employee Count: ~160 Quality: ISO 9001, CE Certified
Products: Spirometers, Autoclaves, Hematology Analyzers, Thermometers, Sterilizing Aids, Bags, Wraps & Tubing, ...
Propper Manufacturing Co. Inc. produces sterilization medical/surgical products, laboratory products, fecal occult blood test diagnostic kits and diagnostic instruments. We also serve the medical & de more...
www.proppermfg.com | Send Inquiry | Phone: +1-(800)-832-4300
FDA Registration: 2410251 Year Established: 1935 Annual Revenues: USD 25-50 Million Employee Count: ~160 Quality: ISO 9001, CE Certified
Products: Spirometers, Autoclaves, Hematology Analyzers, Thermometers, Sterilizing Aids, Bags, Wraps & Tubing, ...
Propper Manufacturing Co. Inc. produces sterilization medical/surgical products, laboratory products, fecal occult blood test diagnostic kits and diagnostic instruments. We also serve the medical & de more...
Nalge Nunc International | Address: International Department, 75 Panorama Creek Drive, Rochester, New York 14625, USA
www.nalgenunc.com | Send Inquiry | Phone: +1-(800)-625-4327
FDA Registration: 1314344 Year Established: 1949 Annual Revenues: USD 100-500 Million Employee Count: ~900 Quality: ISO, CE Certified
Products: Microplate Washers, Vacuum Manifolds, Plate Sealing Films, Plate Sealing Foils, Centrifuge Aids, General Diagnostic Supplies, ...
Nalge Nunc International is an ISO 13485 certified company. Our hydrometer jar is a one-piece unit, which is transparent, has superior chemical resistance & an upper temperature limit of 135°C. It more...
www.nalgenunc.com | Send Inquiry | Phone: +1-(800)-625-4327
FDA Registration: 1314344 Year Established: 1949 Annual Revenues: USD 100-500 Million Employee Count: ~900 Quality: ISO, CE Certified
Products: Microplate Washers, Vacuum Manifolds, Plate Sealing Films, Plate Sealing Foils, Centrifuge Aids, General Diagnostic Supplies, ...
Nalge Nunc International is an ISO 13485 certified company. Our hydrometer jar is a one-piece unit, which is transparent, has superior chemical resistance & an upper temperature limit of 135°C. It more...
Carolina Biological Supply Company | Address: 2700 York Road, Burlington, North Carolina 27215-3398, USA
www2.carolina.com | Send Inquiry | Phone: +1-(800)-334-5551
FDA Registration: 3003783142 Year Established: 1927 Annual Revenues: USD 10-25 Million Employee Count: ~100
Products: Dissecting Pins, Dissecting T-pins, Dissecting Pins Pack, Dissection kit, Plastic Tubing Clamp, Plastic Tubing, ...
Carolina Biological Supply Company supplies biological and science teaching materials. We deal with living organisms, preserved organisms, life science and lab supplies & equipment. Our trained biolog more...
www2.carolina.com | Send Inquiry | Phone: +1-(800)-334-5551
FDA Registration: 3003783142 Year Established: 1927 Annual Revenues: USD 10-25 Million Employee Count: ~100
Products: Dissecting Pins, Dissecting T-pins, Dissecting Pins Pack, Dissection kit, Plastic Tubing Clamp, Plastic Tubing, ...
Carolina Biological Supply Company supplies biological and science teaching materials. We deal with living organisms, preserved organisms, life science and lab supplies & equipment. Our trained biolog more...
Triangle Biomedical Sciences, Inc. | Address: 3014 Croasdaile Drive, Durham, North Carolina 27705, USA
www.trianglebiomedical.com | Send Inquiry | Phone: +1-(919)-384-9393
FDA Registration: 1055757
Products: General Diagnostic Supplies, General Medical Supplies, Stain Sets & Solutions, Microscope Slides (FDA Code: KEW), Microscope Slides (FDA Code: KEW), Embedding Container (FDA Code: KER), ...
Triangle Biomedical Sciences, Inc. designs, develops, manufactures and markets a comprehensive line of innovative instrumentation, apparatus, reagents and consumables for the medical discipline of his more...
www.trianglebiomedical.com | Send Inquiry | Phone: +1-(919)-384-9393
FDA Registration: 1055757
Products: General Diagnostic Supplies, General Medical Supplies, Stain Sets & Solutions, Microscope Slides (FDA Code: KEW), Microscope Slides (FDA Code: KEW), Embedding Container (FDA Code: KER), ...
Triangle Biomedical Sciences, Inc. designs, develops, manufactures and markets a comprehensive line of innovative instrumentation, apparatus, reagents and consumables for the medical discipline of his more...
Hacker Instruments & Industries Inc | Address: 1132 Kincaid Bridge Road ,PO Box 1176, Winnsboro, South Carolina 29180, USA
www.hackerinstruments.com | Send Inquiry | Phone: +1-(803)-712-6100
Year Established: 1942 Annual Revenues: USD 1-5 Million Quality: CE Certified
Products: Coverslippers, Paraffin Embedding Stations, Tissue Processors, Tissue Processors Refurbished, Semi-enclosed Tissue Processors, Microwave Tissue Processors, ...
Hacker Instruments & Industries Inc offers a comprehensive range of instruments that ensure possible preparation of the histological tissue specimens. We offer products like sales & services, coversli more...
www.hackerinstruments.com | Send Inquiry | Phone: +1-(803)-712-6100
Year Established: 1942 Annual Revenues: USD 1-5 Million Quality: CE Certified
Products: Coverslippers, Paraffin Embedding Stations, Tissue Processors, Tissue Processors Refurbished, Semi-enclosed Tissue Processors, Microwave Tissue Processors, ...
Hacker Instruments & Industries Inc offers a comprehensive range of instruments that ensure possible preparation of the histological tissue specimens. We offer products like sales & services, coversli more...
One Lambda, Inc. | Address: 21001 Kittridge St., Canoga Park, California 91303, USA
www.onelambda.com | Send Inquiry | Phone: +1-(818)-702-0042, 800-822-8824
FDA Registration: 2024375 Annual Revenues: < USD 1 Million Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Anti-acetylcholine Receptor Alpha Monoclonal Antibody, Monoclonal Antibody Test, Leukocyte Typing Test (FDA Code: LGO), Lymphocyte Separation Medium (FDA Code: JCF), Microscope Slide Coverslip (FDA Code: KES), Microscope Stage (FDA Code: KEJ), ...
One Lambda, Inc. develops and distributes several lines of histocompatibility typing tests utilizing both serological and molecular technologies. We manufacture a comprehensive line of antibody detect more...
www.onelambda.com | Send Inquiry | Phone: +1-(818)-702-0042, 800-822-8824
FDA Registration: 2024375 Annual Revenues: < USD 1 Million Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Anti-acetylcholine Receptor Alpha Monoclonal Antibody, Monoclonal Antibody Test, Leukocyte Typing Test (FDA Code: LGO), Lymphocyte Separation Medium (FDA Code: JCF), Microscope Slide Coverslip (FDA Code: KES), Microscope Stage (FDA Code: KEJ), ...
One Lambda, Inc. develops and distributes several lines of histocompatibility typing tests utilizing both serological and molecular technologies. We manufacture a comprehensive line of antibody detect more...
Mardx Diagnostics, Inc. | Address: 5919 Farnsworth Ct., Carlsbad, California 92008, USA
Phone: +1-(760)-929-0500
FDA Registration: 2245544 Annual Revenues: USD 5-10 Million
Products: Lyme Disease (Borrelia) Test Kits, Infectious Disease Test Kits, Lyme Disease Test, Legionella Direct & Indirect Fluorescent Antibody Regents (FDA Code: LHL), Streptococcus Spp Antiserum (FDA Code: GTZ), Mounting Media (FDA Code: LEB), ...
Mardx Diagnostics, Inc. is engaged in developing, manufacturing, and marketing of diagnostic products. We offer western blot, IFA, EIA,and ENA IgG marstripe immunostride tests for 6 extractable nuclea more...
Phone: +1-(760)-929-0500
FDA Registration: 2245544 Annual Revenues: USD 5-10 Million
Products: Lyme Disease (Borrelia) Test Kits, Infectious Disease Test Kits, Lyme Disease Test, Legionella Direct & Indirect Fluorescent Antibody Regents (FDA Code: LHL), Streptococcus Spp Antiserum (FDA Code: GTZ), Mounting Media (FDA Code: LEB), ...
Mardx Diagnostics, Inc. is engaged in developing, manufacturing, and marketing of diagnostic products. We offer western blot, IFA, EIA,and ENA IgG marstripe immunostride tests for 6 extractable nuclea more...
Dako North America, Inc. | Address: 6392 Via Real, Carpinteria, California 93013, USA
www.dakousa.com | Send Inquiry | Phone: +1-(805)-566-6655, 800-235-5743
FDA Registration: 2022180 Annual Revenues: USD 25-50 Million Employee Count: ~180 Quality: ISO 9001 Certified
Products: Albumin Antigen Antiserum Control (FDA Code: DCF), Albumin, FITC Conjugate (FDA Code: DDZ), 2 Herpesvirus Hominis 1 Cf Antisera (FDA Code: GQO), 2 Herpesvirus Hominis 1 Fluorescent Antisera (FDA Code: GQL), Acid Fuchsin Stain (FDA Code: IDF), Alcian Blue Stain (FDA Code: IDA), ...
Dako North America, Inc. focuses on tissue-based cancer diagnostics like immunohistochemistry, in situ hybridization, flow cytometry, bulk antibodies for turbidometry and ELISA kits. We provide reagen more...
www.dakousa.com | Send Inquiry | Phone: +1-(805)-566-6655, 800-235-5743
FDA Registration: 2022180 Annual Revenues: USD 25-50 Million Employee Count: ~180 Quality: ISO 9001 Certified
Products: Albumin Antigen Antiserum Control (FDA Code: DCF), Albumin, FITC Conjugate (FDA Code: DDZ), 2 Herpesvirus Hominis 1 Cf Antisera (FDA Code: GQO), 2 Herpesvirus Hominis 1 Fluorescent Antisera (FDA Code: GQL), Acid Fuchsin Stain (FDA Code: IDF), Alcian Blue Stain (FDA Code: IDA), ...
Dako North America, Inc. focuses on tissue-based cancer diagnostics like immunohistochemistry, in situ hybridization, flow cytometry, bulk antibodies for turbidometry and ELISA kits. We provide reagen more...
CAL Glass For Research, Inc. | Address: 3012 Enterprise St., Costa Mesa, California 92626, USA
Send Inquiry | Phone: +1-(714)-546-7250
Year Established: 1960 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Micro Pipette (FDA Code: JRC), Labware, Buret, Burner, Labeled Medical Laboratory Equipment (FDA Code: LXG), Laboratory Manometer, Macro Pipette, ...
CAL Glass For Research, Inc. specializes in engineering & manufacturing of custom quartz and pyrex apparatus including turnkey distillation systems. We manufacture glass instruments, laboratory equipm more...
Send Inquiry | Phone: +1-(714)-546-7250
Year Established: 1960 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Micro Pipette (FDA Code: JRC), Labware, Buret, Burner, Labeled Medical Laboratory Equipment (FDA Code: LXG), Laboratory Manometer, Macro Pipette, ...
CAL Glass For Research, Inc. specializes in engineering & manufacturing of custom quartz and pyrex apparatus including turnkey distillation systems. We manufacture glass instruments, laboratory equipm more...
Tiger Medical Products (us), Inc. | Address: 17328, Ventura Blvd., No. 245, Encino, California 91316, USA
Phone: +1-(310)-614-1997
Products: Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Tracheal Tube with/without Connector (FDA Code: BTR), Manual Stethoscope (FDA Code: LDE), Medical Absorbent Fiber (FDA Code: FRL), Mechanical Walker (FDA Code: ITJ), ...
Tiger Medical Products (us), Inc. provides tongue depressors, adhesive bandages, medical absorbent fibers, mechanical walkers and manual stethoscopes. more...
Phone: +1-(310)-614-1997
Products: Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Tracheal Tube with/without Connector (FDA Code: BTR), Manual Stethoscope (FDA Code: LDE), Medical Absorbent Fiber (FDA Code: FRL), Mechanical Walker (FDA Code: ITJ), ...
Tiger Medical Products (us), Inc. provides tongue depressors, adhesive bandages, medical absorbent fibers, mechanical walkers and manual stethoscopes. more...
Medical Concepts, Inc., | Address: 41558 Eastman Dr., Suite D, Murrieta, California 92562, USA
www.medicalconceptsinc.com | Send Inquiry | Phone: +1-(951)-8947348 800-844-3059
FDA Registration: 2951117
Products: Instrument Trays, Bandages, Ear Protector Mold Kit, Ear Dressing Forceps, Ear Plug, Bone Particle Collector (FDA Code: MXP), ...
Medical Concepts, Inc., provides product in the field of otolaryngology which deals with the diagnosis and treatment of diseases of the ear, nose and throat. We also provide mastoid surgical produts a more...
www.medicalconceptsinc.com | Send Inquiry | Phone: +1-(951)-8947348 800-844-3059
FDA Registration: 2951117
Products: Instrument Trays, Bandages, Ear Protector Mold Kit, Ear Dressing Forceps, Ear Plug, Bone Particle Collector (FDA Code: MXP), ...
Medical Concepts, Inc., provides product in the field of otolaryngology which deals with the diagnosis and treatment of diseases of the ear, nose and throat. We also provide mastoid surgical produts a more...
American Laboratory Supply LLC | Address: 14702 Seventh Avenue East, Bradenton, Florida 34212, USA
Products: Microscope Slides (FDA Code: KEW), Microscope Slide Coverslip (FDA Code: KES), ...
American Laboratory Supply LLC is a wholesaler of laboratory equipment and supplies. Our product line includes microscope slides, countertop laboratory equipment, and micro cabinets. more...
Products: Microscope Slides (FDA Code: KEW), Microscope Slide Coverslip (FDA Code: KES), ...
American Laboratory Supply LLC is a wholesaler of laboratory equipment and supplies. Our product line includes microscope slides, countertop laboratory equipment, and micro cabinets. 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), Adult Tongue Depressor (FDA Code: FMA), Hydrophilic Wound Dressings (FDA Code: NAC), Blood Collection Lancet (FDA Code: FMK), Emesis Basin (FDA Code: FNY), Elastic Stocking (FDA Code: ILG), ...
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), Adult Tongue Depressor (FDA Code: FMA), Hydrophilic Wound Dressings (FDA Code: NAC), Blood Collection Lancet (FDA Code: FMK), Emesis Basin (FDA Code: FNY), Elastic Stocking (FDA Code: ILG), ...
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...
Mercedes Medical | Address: 7590 Commerce Court, Sarasota, Florida 34243, USA
mercedesmedical.com | Send Inquiry | Phone: +1-(800)-331-2716
FDA Registration: 1063851
Products: Air Filtration System, Acrylic Glove Box Holders, Biopsy Cassettes, Blood Collection Systems (FDA Code: JKA), Cell Adhesive Slide, Chemical Solution Stain (FDA Code: LED), ...
Mercedes Medical offers clinical and histology products. Our patient apparel include exam caps, exam gowns, drape sheets and miscellaneous apparel. We supply orthopedic splints and supports. Our surgi more...
mercedesmedical.com | Send Inquiry | Phone: +1-(800)-331-2716
FDA Registration: 1063851
Products: Air Filtration System, Acrylic Glove Box Holders, Biopsy Cassettes, Blood Collection Systems (FDA Code: JKA), Cell Adhesive Slide, Chemical Solution Stain (FDA Code: LED), ...
Mercedes Medical offers clinical and histology products. Our patient apparel include exam caps, exam gowns, drape sheets and miscellaneous apparel. We supply orthopedic splints and supports. Our surgi more...
Advandx, Inc. | Address: 10a Roessler Road, Woburn, Massachusetts 01801, USA
www.advandx.com | Send Inquiry | Phone: +1-(781)-376-0009
FDA Registration: 3004080598
Products: Diagnostic Test Kits, Molecular Diagnostic Services, Enterobacteriaceae Identification Kit (FDA Code: JSS), Yeast Identification Kit (FDA Code: JXB), Infection Prevention Solutions, In Vitro Immunodiagnostic Test Systems, ...
AdvanDx Inc. deals with molecular-based in-vitro diagnostic tests. Our molecular-based in-vitro diagnostic tests aid in the diagnosis and prevention of infectious diseases. We offer PNA Fish™ an more...
www.advandx.com | Send Inquiry | Phone: +1-(781)-376-0009
FDA Registration: 3004080598
Products: Diagnostic Test Kits, Molecular Diagnostic Services, Enterobacteriaceae Identification Kit (FDA Code: JSS), Yeast Identification Kit (FDA Code: JXB), Infection Prevention Solutions, In Vitro Immunodiagnostic Test Systems, ...
AdvanDx Inc. deals with molecular-based in-vitro diagnostic tests. Our molecular-based in-vitro diagnostic tests aid in the diagnosis and prevention of infectious diseases. We offer PNA Fish™ an more...
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FDA Code / Regulation: KES / 864.3010
Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.
Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. The devices are also 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, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
