Dye Solution Stain Suppliers
Limit companies to: Worldwide USA
EMAIL INQUIRY to 20 suppliers
Ventana Medical Systems, Inc. | Address: 1910 Innovation Park Dr., Tucson, Arizona 85755, USA 
www.ventanamed.com | Send Inquiry | Phone: +1-(520)-887-2155, 800-227-2155
FDA Registration: 2028492 Year Established: 1991 Employee Count: ~950
Products: Probes (FDA Code: HXB), Trabeculotomy Probes, Mini-Lacrimal Probes, Laser Surgical Systems, Laser Illumination Probes, Pigtail Curved Blunt Probes, Surgical Instruments, Bone Awls and Probes, ...
Ventana Medical Systems, Inc. deals with diagnostic instruments and reagent systems for use in slide-based diagnosis of cancer and infectious disease. Our products are found in hospital-based histolog more...
www.ventanamed.com | Send Inquiry | Phone: +1-(520)-887-2155, 800-227-2155
FDA Registration: 2028492 Year Established: 1991 Employee Count: ~950
Products: Probes (FDA Code: HXB), Trabeculotomy Probes, Mini-Lacrimal Probes, Laser Surgical Systems, Laser Illumination Probes, Pigtail Curved Blunt Probes, Surgical Instruments, Bone Awls and Probes, ...
Ventana Medical Systems, Inc. deals with diagnostic instruments and reagent systems for use in slide-based diagnosis of cancer and infectious disease. Our products are found in hospital-based histolog more...
Biosource International | Address: 542 Flynn Road, Camarillo, California 93012, USA
www.biosource.com | Send Inquiry | Phone: +1-(800)-242-0607
Annual Revenues: USD 25-50 Million
Products: Super Broth, Terrific Broth, LB Broth, Gentamicin, Pen-Strep, Liquid Bacterial Media Misc, ...
Biosource International offers a comprehensive suite of sensitive & specific elisas, luminex assays, recombinant proteins & antibodies for analysis of multiple proteins and pathways. We offer products more...
www.biosource.com | Send Inquiry | Phone: +1-(800)-242-0607
Annual Revenues: USD 25-50 Million
Products: Super Broth, Terrific Broth, LB Broth, Gentamicin, Pen-Strep, Liquid Bacterial Media Misc, ...
Biosource International offers a comprehensive suite of sensitive & specific elisas, luminex assays, recombinant proteins & antibodies for analysis of multiple proteins and pathways. We offer products more...
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...
Cancer Diagnostics, Inc. | Address: P.O. Box 1205, Birmingham, Michigan 48012-1205, USA
www.cancerdiagnostics.com | Send Inquiry | Phone: +1-(408)-980-7392, 919-744-5564
FDA Registration: 3007496191
Products: Scalpels, Eyeshields, Disposable Surgical scalpels, Tissue Marking Dyes, Base Mold Release Agent and Sprays, Squeezable Tissue Marking Dyes, ...
Cancer Diagnostics, Inc. manufactures specialty products for the pathology laboratory. Our product list comprises of tissue marking dyes, scalpels, knives, grossing pads & rulers, cassettes, biopsy ba more...
www.cancerdiagnostics.com | Send Inquiry | Phone: +1-(408)-980-7392, 919-744-5564
FDA Registration: 3007496191
Products: Scalpels, Eyeshields, Disposable Surgical scalpels, Tissue Marking Dyes, Base Mold Release Agent and Sprays, Squeezable Tissue Marking Dyes, ...
Cancer Diagnostics, Inc. manufactures specialty products for the pathology laboratory. Our product list comprises of tissue marking dyes, scalpels, knives, grossing pads & rulers, cassettes, biopsy ba more...
Richard-Allan Scientific | Address: 4481 Campus Drive, Kalamazoo, Michigan 49008, USA
www.rallansci.com | Send Inquiry | Phone: +1-(269)-544-5600
FDA Registration: 1831638
Products: Slide Stainers, Slide Staining, General Medical Supplies, General Diagnostics, General Urology Supplies, General Disinfectants, ...
Richard-allan Scientific produces a complete portfolio of consumable & supplies for the histology, cytology and hematology lab community. We specialize in performance stains, reagents, paraffin, prefi more...
www.rallansci.com | Send Inquiry | Phone: +1-(269)-544-5600
FDA Registration: 1831638
Products: Slide Stainers, Slide Staining, General Medical Supplies, General Diagnostics, General Urology Supplies, General Disinfectants, ...
Richard-allan Scientific produces a complete portfolio of consumable & supplies for the histology, cytology and hematology lab community. We specialize in performance stains, reagents, paraffin, prefi more...
SIGMA-ALDRICH CORP | Address: 3050 Spruce St., St. Louis, Missouri 63103, USA
www.sigmaaldrich.com | Send Inquiry | Phone: +1-(800)-521-8956
FDA Registration: 1937991 Annual Revenues: USD 50-100 Million Employee Count: ~8000 Quality: ISO 9000, ISO 9001 Certified
Products: Chemical Supplies, Blood, Hematology Analyzers, Automated Hematology Analyzers, Bench-top PCR Hoods, Chromatography Apparatus, Balanced Salt Solutions (FDA Code: KIP), ...
Sigma-Aldrich is a life science and high technology company. We are an ISO 9000 & ISO 9001 certified company. We offer products such as vitals, titration, syringes, solid phase microextraction, purifi more...
www.sigmaaldrich.com | Send Inquiry | Phone: +1-(800)-521-8956
FDA Registration: 1937991 Annual Revenues: USD 50-100 Million Employee Count: ~8000 Quality: ISO 9000, ISO 9001 Certified
Products: Chemical Supplies, Blood, Hematology Analyzers, Automated Hematology Analyzers, Bench-top PCR Hoods, Chromatography Apparatus, Balanced Salt Solutions (FDA Code: KIP), ...
Sigma-Aldrich is a life science and high technology company. We are an ISO 9000 & ISO 9001 certified company. We offer products such as vitals, titration, syringes, solid phase microextraction, purifi more...
Becton, Dickson & Co., | Address: One Becton Drive, Franklin Lakes, New Jersey 07417, USA
www.bd.com/us | Phone: +1-(201)-847.6800
FDA Registration: 1119779 Annual Revenues: USD 10-25 Million Employee Count: ~1600 Quality: ISO 9000, CE Certified
Products: Software Programs, CCD Cameras, & Gamma Cameras, Biomedical Devices, 3D Imaging Devices, Frame Grabbers, Densitometers Accessories, ...
Becton, Dickinson & Co., manufactures and distributes a broad range of medical supplies, devices, laboratory equipment and diagnostic products. Our product BD Soluvia™ is a prefillable microinje more...
www.bd.com/us | Phone: +1-(201)-847.6800
FDA Registration: 1119779 Annual Revenues: USD 10-25 Million Employee Count: ~1600 Quality: ISO 9000, CE Certified
Products: Software Programs, CCD Cameras, & Gamma Cameras, Biomedical Devices, 3D Imaging Devices, Frame Grabbers, Densitometers Accessories, ...
Becton, Dickinson & Co., manufactures and distributes a broad range of medical supplies, devices, laboratory equipment and diagnostic products. Our product BD Soluvia™ is a prefillable microinje more...
BD Diagnostics - TriPath | Address: 780 Plantation Drive, Burlington, North Carolina 27215, USA
www.tripathimaging.com | Send Inquiry | Phone: +1-(336)-222-9707
FDA Registration: 1062336
Products: Diagnostic Aids, Blood Analyzer Reagents, Calibrators for Equipment, Chemistry Analyzers, Coagulation Lab Testing, Controls, ...
BD Diagnostics - TriPath develops and distributes solutions to improve the clinical management of cancer, including detection, diagnosis, staging and treatment. Our BD ProEx™ C reagent is a high more...
www.tripathimaging.com | Send Inquiry | Phone: +1-(336)-222-9707
FDA Registration: 1062336
Products: Diagnostic Aids, Blood Analyzer Reagents, Calibrators for Equipment, Chemistry Analyzers, Coagulation Lab Testing, Controls, ...
BD Diagnostics - TriPath develops and distributes solutions to improve the clinical management of cancer, including detection, diagnosis, staging and treatment. Our BD ProEx™ C reagent is a high 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...
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...
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...
Dentsply Caulk | Address: 38 W. Clarke Avenue, Milford, Delaware 19963, USA
www.caulk.com | Send Inquiry | Phone: +1-(800)-532-2855
FDA Registration: 2515379 Year Established: 1877 Annual Revenues: USD 50-100 Million Employee Count: ~9400 Quality: ISO 9000, ISO 9001, CE Certified
Products: General Medical Supplies, General Surgery Supplies, X-Ray Accessories, Leaded Aprons (FDA Code: EAJ), Flexible Padded Abdominal Retractor, Liquid Medication Dispenser (FDA Code: KYX), Endoscope Cleaning Brushes & Accessories (FDA Code: MNL), ...
Dentsply Caulk offers dental products. Our product categories are alloys & accessories, bone grafting materials, burs, cements & liners, impression materials, irrigation probes, and x-ray products. Ou more...
www.caulk.com | Send Inquiry | Phone: +1-(800)-532-2855
FDA Registration: 2515379 Year Established: 1877 Annual Revenues: USD 50-100 Million Employee Count: ~9400 Quality: ISO 9000, ISO 9001, CE Certified
Products: General Medical Supplies, General Surgery Supplies, X-Ray Accessories, Leaded Aprons (FDA Code: EAJ), Flexible Padded Abdominal Retractor, Liquid Medication Dispenser (FDA Code: KYX), Endoscope Cleaning Brushes & Accessories (FDA Code: MNL), ...
Dentsply Caulk offers dental products. Our product categories are alloys & accessories, bone grafting materials, burs, cements & liners, impression materials, irrigation probes, and x-ray products. Ou more...
Delasco | Address: 608 13th Ave, Council Bluffs, Iowa 51501, USA
www.delasco.com | Send Inquiry | Phone: +1-(800)-831-6273
FDA Registration: 1930126 Year Established: 1980 Quality: CE Certified
Products: General Surgical Instruments, Surgical Lighting, Medical Lighting, Acne Scar Treatments, Single Use Surgical Instruments, Microdermabrasion Devices, ...
Delasco supplies dermatologic products. We offer personal skin care products recommended by a dermatologist. We supply acne products, eczema products and alopecia products. We provide regine cosmetic more...
www.delasco.com | Send Inquiry | Phone: +1-(800)-831-6273
FDA Registration: 1930126 Year Established: 1980 Quality: CE Certified
Products: General Surgical Instruments, Surgical Lighting, Medical Lighting, Acne Scar Treatments, Single Use Surgical Instruments, Microdermabrasion Devices, ...
Delasco supplies dermatologic products. We offer personal skin care products recommended by a dermatologist. We supply acne products, eczema products and alopecia products. We provide regine cosmetic more...
Ricca Chemical Company LLC | Address: 1841 Broad St., Pocomoke City, Maryland 21851, USA
www.riccachemical.com | Send Inquiry | Phone: +1-(817)-461-5601, 888-467-4222
FDA Registration: 1125908 Year Established: 2000 Quality: ISO 9001 Certified
Products: Clinical Diagnostic Solutions, Hematology Reagents, Cytology Test Stains, Hematology Stain (FDA Code: KQC), Red Cell Diluting Fluid (FDA Code: GJN), General Purpose Reagent (FDA Code: LDT), Papanicolau Stain (FDA Code: HZJ), ...
Ricca Chemical Company LLC manufactures chemical testing solutions. We offer diluting fluids, screening fluids, and stains for blood analysis. We also offer stains like papanicolaou (pap) for cervical more...
www.riccachemical.com | Send Inquiry | Phone: +1-(817)-461-5601, 888-467-4222
FDA Registration: 1125908 Year Established: 2000 Quality: ISO 9001 Certified
Products: Clinical Diagnostic Solutions, Hematology Reagents, Cytology Test Stains, Hematology Stain (FDA Code: KQC), Red Cell Diluting Fluid (FDA Code: GJN), General Purpose Reagent (FDA Code: LDT), Papanicolau Stain (FDA Code: HZJ), ...
Ricca Chemical Company LLC manufactures chemical testing solutions. We offer diluting fluids, screening fluids, and stains for blood analysis. We also offer stains like papanicolaou (pap) for cervical more...
Anatech, Ltd. | Address: 1020 Harts Lake Rd., Battle Creek, Michigan 49015-1065, USA
www.anatechltdusa.com | Send Inquiry | Phone: +1-(269)-964-6450, 800-262-8324
FDA Registration: 1831338 Annual Revenues: USD 1-5 Million
Products: Histopathology Reference Laboratory, Hematoxylin Stain (FDA Code: HYJ), Alcohol Containing Fixative (FDA Code: LDZ), Formaldehyde (FDA Code: IGG), General Purpose Reagent (FDA Code: LDT), Neutral Buffered Formalin (FDA Code: IFP), ...
Anatech, Ltd. is a designer, manufacturer and retailer of products for histopathology laboratories. We have a complete line of fixing, processing and staining fluids intended to produce preparations f more...
www.anatechltdusa.com | Send Inquiry | Phone: +1-(269)-964-6450, 800-262-8324
FDA Registration: 1831338 Annual Revenues: USD 1-5 Million
Products: Histopathology Reference Laboratory, Hematoxylin Stain (FDA Code: HYJ), Alcohol Containing Fixative (FDA Code: LDZ), Formaldehyde (FDA Code: IGG), General Purpose Reagent (FDA Code: LDT), Neutral Buffered Formalin (FDA Code: IFP), ...
Anatech, Ltd. is a designer, manufacturer and retailer of products for histopathology laboratories. We have a complete line of fixing, processing and staining fluids intended to produce preparations f more...
Trigon Technology, Inc. | Address: 23126 South Shore Drive, Edwardsburg, Michigan 49112, USA
Phone: +1-(269)-699-7182
Products: Dye Solution Stain (FDA Code: LEE), ...
Trigon Technology, Inc. specializes in providing dye solution stains. more...
Phone: +1-(269)-699-7182
Products: Dye Solution Stain (FDA Code: LEE), ...
Trigon Technology, Inc. specializes in providing dye solution stains. more...
Radiation Products Design, Inc. | Address: 5218 Barthel Industrial Dr., Albertville, Minnesota 55301-9766, USA
www.rpdinc.com | Send Inquiry | Phone: +1-(763)-4972071, 800-4972071
FDA Registration: 2182762 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: CT Scanners, Disposable Examination Nitrile Gloves, Digital Thermometers, Back Supports, Curved Tying Forceps, CT Stimulators, ...
Radiation Products Design, Inc. is a provider of patient and personal care products such as varieties of gloves, gels, back & wrist supports, lotions and wall mounted stadiometers. We offer latex & su more...
www.rpdinc.com | Send Inquiry | Phone: +1-(763)-4972071, 800-4972071
FDA Registration: 2182762 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: CT Scanners, Disposable Examination Nitrile Gloves, Digital Thermometers, Back Supports, Curved Tying Forceps, CT Stimulators, ...
Radiation Products Design, Inc. is a provider of patient and personal care products such as varieties of gloves, gels, back & wrist supports, lotions and wall mounted stadiometers. We offer latex & su more...
Polysciences Inc | Address: 400 Valley Rd, Warrington, Pennsylvania 18976, USA
www.polysciences.com | Send Inquiry | Phone: +1-(800)-523-2575
FDA Registration: 2518071 Year Established: 1961 Annual Revenues: USD 10-25 Million Employee Count: ~80 Quality: CE Certified
Products: Disposable Examination Gloves, Controls for Diagnostic Equipment, Disposable Gloves, Disposable Examination Latex Gloves, Latex Disposable Gloves, Disposable Examination Nitrile Gloves, ...
Polysciences Inc manufactures raw materials for research institutions, medical devices and industrial chemistry. Our chemical products are used in many scientific applications. Our product line includ more...
www.polysciences.com | Send Inquiry | Phone: +1-(800)-523-2575
FDA Registration: 2518071 Year Established: 1961 Annual Revenues: USD 10-25 Million Employee Count: ~80 Quality: CE Certified
Products: Disposable Examination Gloves, Controls for Diagnostic Equipment, Disposable Gloves, Disposable Examination Latex Gloves, Latex Disposable Gloves, Disposable Examination Nitrile Gloves, ...
Polysciences Inc manufactures raw materials for research institutions, medical devices and industrial chemistry. Our chemical products are used in many scientific applications. Our product line includ more...
Cellpath Ltd. | Address: 80 Mochdre Enterprise Park, Newtown, GB-POW SY16 4LE, United Kingdom 
www.cellpath.co.uk | Phone: +44-(01686)-611 333
FDA Registration: 3005787343
Products: Microscope Slides (FDA Code: KEW), Microscope Slides (FDA Code: KEW), Dye Solution Stain (FDA Code: LEE), Embedding Container (FDA Code: KER), Giemsa Stain (FDA Code: HYF), Microscope Slide Coverslip (FDA Code: KES), ...
Cellpath Ltd. is a provider of monoclonal and concentrated antibodies. Our product line includes microscope slides, electrically heated forceps, and tissue marking dyes. Our Cellceps are electrically more...
www.cellpath.co.uk | Phone: +44-(01686)-611 333
FDA Registration: 3005787343
Products: Microscope Slides (FDA Code: KEW), Microscope Slides (FDA Code: KEW), Dye Solution Stain (FDA Code: LEE), Embedding Container (FDA Code: KER), Giemsa Stain (FDA Code: HYF), Microscope Slide Coverslip (FDA Code: KES), ...
Cellpath Ltd. is a provider of monoclonal and concentrated antibodies. Our product line includes microscope slides, electrically heated forceps, and tissue marking dyes. Our Cellceps are electrically more...
Serbio | Address: 125 Avenue Louis Roche, Gennevilliers 92230, France
Phone: 33-146-88 20
Products: Histidine Chromatographic Test (FDA Code: JMI), Platelet Control (FDA Code: GJP), Qualitative and Quantitative Factor Deficiency Test (FDA Code: GGP), Alpha-2-Glycoproteins (FDA Code: DEJ), Antithrombin III Control (FDA Code: DDQ), Beta 2-Glycoprotein I (FDA Code: DDN), ...
Serbio deals with the standardization of immunoassays for antiphospholipid antibodies. more...
Phone: 33-146-88 20
Products: Histidine Chromatographic Test (FDA Code: JMI), Platelet Control (FDA Code: GJP), Qualitative and Quantitative Factor Deficiency Test (FDA Code: GGP), Alpha-2-Glycoproteins (FDA Code: DEJ), Antithrombin III Control (FDA Code: DDQ), Beta 2-Glycoprotein I (FDA Code: DDN), ...
Serbio deals with the standardization of immunoassays for antiphospholipid antibodies. more...
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EMAIL INQUIRY to 20 Dye Solution Stain suppliers
FDA Code / Regulation: LEE / 864.1850
Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.
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. These 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.
