Microscope Slides 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, Procedure Trays, Retractors, Esophageal Stethoscopes (FDA Code: BZW), Aspirators, ...
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, Procedure Trays, Retractors, Esophageal Stethoscopes (FDA Code: BZW), Aspirators, ...
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...
Wescor Inc. | Address: 370 West 1700 South, Logan, Utah 84321, USA
www.wescor.com | Send Inquiry | Phone: +1-(435)-752-6011, 800- 453-2725
FDA Registration: 1717966 Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO, CE Certified
Products: Slide Stainers, General Diagnostic Supplies, Programmable Slide Stainers, Hematology Slide Stainer Instruments, Neurology Instruments, General Chemistry Kits, ...
Wescor manufactures & markets instrumentation & other products for medicine, science and industry. Our unique vapor pressure and colloid osmometers, automatic slide stainers, cytocentrifuges & diagnos more...
www.wescor.com | Send Inquiry | Phone: +1-(435)-752-6011, 800- 453-2725
FDA Registration: 1717966 Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO, CE Certified
Products: Slide Stainers, General Diagnostic Supplies, Programmable Slide Stainers, Hematology Slide Stainer Instruments, Neurology Instruments, General Chemistry Kits, ...
Wescor manufactures & markets instrumentation & other products for medicine, science and industry. Our unique vapor pressure and colloid osmometers, automatic slide stainers, cytocentrifuges & diagnos 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...
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...
American Mastertech Scientific, Inc. | Address: 1330 Thurman St., Lodi, California 95240, USA
www.americanmastertech.com | Phone: +1-(209)-368-4031, 800-860-4073
FDA Registration: 2939235 Quality: ISO 9001:2008 Certified
Products: Acid Containing Decalcifier Pathology Solution (FDA Code: KDX), Acid Containing Fixative (FDA Code: LDW), Acid Fuchsin Stain (FDA Code: IDF), Albumin Based Adhesive (FDA Code: KEL), Alcian Blue Stain (FDA Code: IDA), Alcohol Containing Fixative (FDA Code: LDZ), ...
American Mastertech Scientific, Inc. manufactures and distributes laboratory products & services for hospitals & laboratories. We focus on serving the fields of biology, cytopathology (cytology), hist more...
www.americanmastertech.com | Phone: +1-(209)-368-4031, 800-860-4073
FDA Registration: 2939235 Quality: ISO 9001:2008 Certified
Products: Acid Containing Decalcifier Pathology Solution (FDA Code: KDX), Acid Containing Fixative (FDA Code: LDW), Acid Fuchsin Stain (FDA Code: IDF), Albumin Based Adhesive (FDA Code: KEL), Alcian Blue Stain (FDA Code: IDA), Alcohol Containing Fixative (FDA Code: LDZ), ...
American Mastertech Scientific, Inc. manufactures and distributes laboratory products & services for hospitals & laboratories. We focus on serving the fields of biology, cytopathology (cytology), hist more...
United Biotech, Inc. | Address: 211 S. Whisman Road, Suite E, Mountain View, California 94041, USA
www.unitedbiotech.com | Send Inquiry | Phone: +1-(650)-961-2910
Year Established: 1984 Annual Revenues: USD 1-5 Million Quality: ISO 13485:2003, CE Certified
Products: Autoimmune Test Kits, Chromogenic Substrates, ELISA Kits for Autoimmune Diseases, ELISA Kits for Infectious Diseases& Parasitology, Cancer Marker Tests, Cysticercosis Reagent (FDA Code: MDJ), ...
United Biotech, Inc. develops and manufactures quantitative test products for medical professionals. Our Magiwell™ Anti-ds-DNA semi-quantitative test provides semi-quantitative measurement of an more...
www.unitedbiotech.com | Send Inquiry | Phone: +1-(650)-961-2910
Year Established: 1984 Annual Revenues: USD 1-5 Million Quality: ISO 13485:2003, CE Certified
Products: Autoimmune Test Kits, Chromogenic Substrates, ELISA Kits for Autoimmune Diseases, ELISA Kits for Infectious Diseases& Parasitology, Cancer Marker Tests, Cysticercosis Reagent (FDA Code: MDJ), ...
United Biotech, Inc. develops and manufactures quantitative test products for medical professionals. Our Magiwell™ Anti-ds-DNA semi-quantitative test provides semi-quantitative measurement of an 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, Adhesive Elastic Bandage Tape, Cotton Balls, Cohesive Elastic Bandage, Sterile Shoulder Suspension Kit, Single-Use Procedural Kits, ...
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, Adhesive Elastic Bandage Tape, Cotton Balls, Cohesive Elastic Bandage, Sterile Shoulder Suspension Kit, Single-Use Procedural Kits, ...
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: Adult Tracheostomy Mask, Aspirators, Disposable Leg Bags, Cervical Scrapers, Central Line Dressing Change Trays, Coiled Sterile Suction Catheter, ...
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: Adult Tracheostomy Mask, Aspirators, Disposable Leg Bags, Cervical Scrapers, Central Line Dressing Change Trays, Coiled Sterile Suction Catheter, ...
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...
Biogenex Laboratories | Address: 4600 Norris Canyon Road, San Ramon, California 94583-1320, USA
www.biogenex.com | Send Inquiry | Phone: +1-(925)-275-0550, 800-421-4149
FDA Registration: 3008776165 Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~120 Quality: ISO 9001, CE Certified
Products: Probes (FDA Code: HXB), Microbial Detection Systems, Imaging Systems, Reagents, Molecular Diagnostic Services, Methyl Green Stain (FDA Code: HZA), ...
Biogenex Laboratories specializes in the field of molecular diagnostics. We support cellular & molecular pathology laboratories with a range of reagents, detection kits, antibodies, probes, special st more...
www.biogenex.com | Send Inquiry | Phone: +1-(925)-275-0550, 800-421-4149
FDA Registration: 3008776165 Year Established: 1981 Annual Revenues: USD 10-25 Million Employee Count: ~120 Quality: ISO 9001, CE Certified
Products: Probes (FDA Code: HXB), Microbial Detection Systems, Imaging Systems, Reagents, Molecular Diagnostic Services, Methyl Green Stain (FDA Code: HZA), ...
Biogenex Laboratories specializes in the field of molecular diagnostics. We support cellular & molecular pathology laboratories with a range of reagents, detection kits, antibodies, probes, special st more...
Hardy Diagnostics | Address: 1430 West McCoy Lane, Santa Maria, California 93455, USA
www.hardydiagnostics.com | Send Inquiry | Phone: +1-(805)-346-2766, 800-266-2222
FDA Registration: 2022807 Year Established: 1980 Annual Revenues: USD 10-25 Million Employee Count: ~100
Products: Clinical Microscopes, Pregnancy Kits, Sensitivity Supplies, Home pregnancy test kits, Hcg, Early Pregnancy Testing Kit, Diagnostic Test Kits For Pregnancy, ...
Hardy Diagnostics manufactures over 2,800 products used for the culture and identification of bacteria & fungi. We are accredited with ISO: 13485 certification. Our product line includes rapid test ki more...
www.hardydiagnostics.com | Send Inquiry | Phone: +1-(805)-346-2766, 800-266-2222
FDA Registration: 2022807 Year Established: 1980 Annual Revenues: USD 10-25 Million Employee Count: ~100
Products: Clinical Microscopes, Pregnancy Kits, Sensitivity Supplies, Home pregnancy test kits, Hcg, Early Pregnancy Testing Kit, Diagnostic Test Kits For Pregnancy, ...
Hardy Diagnostics manufactures over 2,800 products used for the culture and identification of bacteria & fungi. We are accredited with ISO: 13485 certification. Our product line includes rapid test ki 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, Automated Urinalysis System (FDA Code: KQO), Culture Tubes, Blood Diluting Pipettes, Double-Ended Blood Collection Needle, Diluting Pipette (FDA Code: GGY), ...
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, Automated Urinalysis System (FDA Code: KQO), Culture Tubes, Blood Diluting Pipettes, Double-Ended Blood Collection Needle, Diluting Pipette (FDA Code: GGY), ...
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...
Small Parts, Inc. | Address: 15901 Sw 29th Street, Hollywood, Florida 33027, USA
www.smallparts.com | Phone: +1-(513)-5730085
Quality: IS0 9001:2000 Certified
Products: Forceps (FDA Code: HTD), Glove Aids, Microscope Slides (FDA Code: KEW), Disposable Dispensing Needle, Liquid Medication Dispenser (FDA Code: KYX), Disposable Syringe Filters, ...
Small Parts, Inc. specializes in the production of clinical products. Our products include adult tongue depressors, forceps, infant tongue depressors, junior tongue depressors and liquid medication di more...
www.smallparts.com | Phone: +1-(513)-5730085
Quality: IS0 9001:2000 Certified
Products: Forceps (FDA Code: HTD), Glove Aids, Microscope Slides (FDA Code: KEW), Disposable Dispensing Needle, Liquid Medication Dispenser (FDA Code: KYX), Disposable Syringe Filters, ...
Small Parts, Inc. specializes in the production of clinical products. Our products include adult tongue depressors, forceps, infant tongue depressors, junior tongue depressors and liquid medication di more...
Biosafe Supplies, LLC | Address: 4751 Distribution Ct #12, Orlando, Florida 32822, USA
www.biosafesupplies.com | Send Inquiry | Phone: +1-(407)-281-6658
Products: Microscope Slides (FDA Code: KEW), Blood Tube Mixer (FDA Code: GLE), Alcohol Containing Fixative (FDA Code: LDZ), Formalin Containing Fixative (FDA Code: LDY), Diagnostic Shipper Kits, Insulated Tube Shippers, ...
Biosafe Supplies, LLC is a provider and manufacturer of pathology kits. Our product line comprises of sterile non-woven gauze sponge, plastic adhesive bandage, cohesive bandages, blood collection tube more...
www.biosafesupplies.com | Send Inquiry | Phone: +1-(407)-281-6658
Products: Microscope Slides (FDA Code: KEW), Blood Tube Mixer (FDA Code: GLE), Alcohol Containing Fixative (FDA Code: LDZ), Formalin Containing Fixative (FDA Code: LDY), Diagnostic Shipper Kits, Insulated Tube Shippers, ...
Biosafe Supplies, LLC is a provider and manufacturer of pathology kits. Our product line comprises of sterile non-woven gauze sponge, plastic adhesive bandage, cohesive bandages, blood collection tube more...
Medline Industries, Inc. | Address: One Medline Place, Mundelein, Illinois 60060, USA
www.medline.com | Send Inquiry | Phone: +1-(800)-633-5463
FDA Registration: 1417592 Year Established: 1966 Annual Revenues: < USD 1 Million Employee Count: ~6800 Quality: ISO 13485 and ISO 11135 Certified
Products: Autoclaves, Scissors, Instrument Stands, Thermometers, Endotracheal Tubes, Aspirators, ...
Medline Industries, Inc. is a manufacturer and distributor of health care supplies & services. We provide products and services to the entire continuum of care, including hospitals, extended care faci more...
www.medline.com | Send Inquiry | Phone: +1-(800)-633-5463
FDA Registration: 1417592 Year Established: 1966 Annual Revenues: < USD 1 Million Employee Count: ~6800 Quality: ISO 13485 and ISO 11135 Certified
Products: Autoclaves, Scissors, Instrument Stands, Thermometers, Endotracheal Tubes, Aspirators, ...
Medline Industries, Inc. is a manufacturer and distributor of health care supplies & services. We provide products and services to the entire continuum of care, including hospitals, extended care faci more...
Surgipath Medical Ind., Inc. | Address: 5205 Route 12, P.O. Box 528, Richmond, Illinois 60071, USA
www.surgipath.com/us-en | Send Inquiry | Phone: +1-(815)-) 678-2000
FDA Registration: 1419341
Products: Laboratory Equipment, Microscope Slides (FDA Code: KEW), Laboratory Consumables,Reagent Reservoirs, Scalpel Blade (FDA Code: GES), Powered Saw and Accessories (FDA Code: HAB), Surgical Knife (FDA Code: EMF), ...
Surgipath Medical Ind., Inc. specializes in the development, manufacture and supply of quality product solutions for the anatomical pathology laboratory. We supply products and services to a vast rang more...
www.surgipath.com/us-en | Send Inquiry | Phone: +1-(815)-) 678-2000
FDA Registration: 1419341
Products: Laboratory Equipment, Microscope Slides (FDA Code: KEW), Laboratory Consumables,Reagent Reservoirs, Scalpel Blade (FDA Code: GES), Powered Saw and Accessories (FDA Code: HAB), Surgical Knife (FDA Code: EMF), ...
Surgipath Medical Ind., Inc. specializes in the development, manufacture and supply of quality product solutions for the anatomical pathology laboratory. We supply products and services to a vast rang more...
Advanced Medical Science & Technology, LLC | Address: 1 Stonegate Court, Suite 01-03, Cockeysville, Maryland 21030, USA
www.advancedmedicals.com | Send Inquiry | Phone: +1-(410)-628-1856
Year Established: 2004
Products: Centrifuges, Microscopes, Fetal Doppler Monitor, Microscope Slides (FDA Code: KEW), Liquid Based Cytology Ststems, Stroke Recovery Systems, ...
Advanced Medical Science & Technology, LLC distributes medical devices. Our product list comprises of microscope systems, microscope slide systems, centrifuge systems, safety syringe systems, fetal do more...
www.advancedmedicals.com | Send Inquiry | Phone: +1-(410)-628-1856
Year Established: 2004
Products: Centrifuges, Microscopes, Fetal Doppler Monitor, Microscope Slides (FDA Code: KEW), Liquid Based Cytology Ststems, Stroke Recovery Systems, ...
Advanced Medical Science & Technology, LLC distributes medical devices. Our product list comprises of microscope systems, microscope slide systems, centrifuge systems, safety syringe systems, fetal do more...
Krolman Corporation | Address: 65 Elm St., Boston, Massachusetts 02129, USA
www.krolman.com | Send Inquiry | Phone: +1-(617)-242-0635, 800-388-3639
FDA Registration: 1225505
Products: Forceps (FDA Code: HTD), Scissors, Trephines, Barraquer Wire Specula, Eye Bank Set, Tissue Bank Service, ...
Krolman Corporation specializes in offering products related to the recovery and processing of allograft tissue from non-living donors. We offer various products for instrument care including steriliz more...
www.krolman.com | Send Inquiry | Phone: +1-(617)-242-0635, 800-388-3639
FDA Registration: 1225505
Products: Forceps (FDA Code: HTD), Scissors, Trephines, Barraquer Wire Specula, Eye Bank Set, Tissue Bank Service, ...
Krolman Corporation specializes in offering products related to the recovery and processing of allograft tissue from non-living donors. We offer various products for instrument care including steriliz 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...
Lide Laboratories, Inc. | Address: 401, 4th. Avenue, S.W., New Prague, Minnesota 56071, USA
www.lidelabs.com | Send Inquiry | Phone: +1-(952)-758-9760
FDA Registration: 1924632
Products: Small Disposable Staining Trays, Microscope Slides (FDA Code: KEW), Giemsa Stain (FDA Code: HYF), In-Vitro Diagnostic Stains, ...
Lide Laboratories, Inc. provides in-vitro diagnostic stains and culture media products. Our Hansel® stain is used for the evaluation of eosinophils and neutrophils in nasal, urine & other secretio more...
www.lidelabs.com | Send Inquiry | Phone: +1-(952)-758-9760
FDA Registration: 1924632
Products: Small Disposable Staining Trays, Microscope Slides (FDA Code: KEW), Giemsa Stain (FDA Code: HYF), In-Vitro Diagnostic Stains, ...
Lide Laboratories, Inc. provides in-vitro diagnostic stains and culture media products. Our Hansel® stain is used for the evaluation of eosinophils and neutrophils in nasal, urine & other secretio more...
Erie Scientific | Address: 20 Post Road, Portsmouth, New Hampshire 03801, USA
www.eriesci.com | Send Inquiry | Phone: +1-(603)-431-8410
FDA Registration: 1219230
Products: Hand Cleaners & Disinfectants, General Diagnostic Supplies, General Medical Supplies, General Examination Supplies, Soap & Soap Dispensers, Light Sources Microscope Light Source, ...
Erie Scientific develops medical instruments. Our microscope slides, coverglass, microarray, diagnostic printed slides and custom specialty glass feature unique coatings, shapes and capabilities for a more...
www.eriesci.com | Send Inquiry | Phone: +1-(603)-431-8410
FDA Registration: 1219230
Products: Hand Cleaners & Disinfectants, General Diagnostic Supplies, General Medical Supplies, General Examination Supplies, Soap & Soap Dispensers, Light Sources Microscope Light Source, ...
Erie Scientific develops medical instruments. Our microscope slides, coverglass, microarray, diagnostic printed slides and custom specialty glass feature unique coatings, shapes and capabilities for a more...
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FDA Code / Regulation: KEW / 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.
