Giemsa Stain Suppliers
Limit companies to: Worldwide USA
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), Laboratory Automation Systems, Microbial Detection Systems, Stainers, Molecular Analyte Specific Reagents (ASR), Trabeculotomy 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), Laboratory Automation Systems, Microbial Detection Systems, Stainers, Molecular Analyte Specific Reagents (ASR), Trabeculotomy 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...
Siemens Healthcare Diagnostics | Address: 1717 Deerfield Road, Deerfield, Illinois 60015-0778, USA
www.usa.siemens.com/diagnostics | Phone: +1-(847)-267-5300
Quality: ISO 9000, CE Certified
Products: Laboratory Automation Systems, Biochemistry Analyzers, Blood Gas Analyzers, Coagulation Analyzers (FDA Code: GKP), Immunoassay Systems, Immunochemistry Analyzers, ...
Siemens Healthcare Diagnostics, a clinical diagnostics company, provides clinicians with the vital information they need for the accurate diagnosis, treatment and monitoring of patients. Our comprehen more...
www.usa.siemens.com/diagnostics | Phone: +1-(847)-267-5300
Quality: ISO 9000, CE Certified
Products: Laboratory Automation Systems, Biochemistry Analyzers, Blood Gas Analyzers, Coagulation Analyzers (FDA Code: GKP), Immunoassay Systems, Immunochemistry Analyzers, ...
Siemens Healthcare Diagnostics, a clinical diagnostics company, provides clinicians with the vital information they need for the accurate diagnosis, treatment and monitoring of patients. Our comprehen 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: Swabs, Chemical Sterilizers (FDA Code: MLR), Coagulation Analyzers (FDA Code: GKP), Myoglobin (FDA Code: DDR), Sliding Microtomes (FDA Code: KFL), Rotary Microtomes (FDA Code: IDO), ...
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: Swabs, Chemical Sterilizers (FDA Code: MLR), Coagulation Analyzers (FDA Code: GKP), Myoglobin (FDA Code: DDR), Sliding Microtomes (FDA Code: KFL), Rotary Microtomes (FDA Code: IDO), ...
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...
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: Hematology Analyzers, Tissue Processors, Prostatic Acid Phosphatase, PCR Hoods, Plate Sealing Films, Plate Sealing Foils, ...
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: Hematology Analyzers, Tissue Processors, Prostatic Acid Phosphatase, PCR Hoods, Plate Sealing Films, Plate Sealing Foils, ...
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...
Biotech Atlantic, Inc. | Address: 6 Industrial Way West, Eatontown, New Jersey 07724, USA
www.lidelabs.com/BAIproducts.html | Send Inquiry | Phone: +1-(732)-389-4789
Products: Myoglobin (FDA Code: DDR), Creatine Kinase Myoglobin Kit, Detection Kits Myoglobin Detection Kit, Human Myoglobin ELISA Kits, Anti-Myoglobin Detection Kit, Myoglobin Ria Test Kit, ...
Biotech Atlantic, Inc. develops and manufactures diagnostic kits & related life science products. We offer products like fertility, drug abuse, infectious disease, sexually transmitted disease & marke more...
www.lidelabs.com/BAIproducts.html | Send Inquiry | Phone: +1-(732)-389-4789
Products: Myoglobin (FDA Code: DDR), Creatine Kinase Myoglobin Kit, Detection Kits Myoglobin Detection Kit, Human Myoglobin ELISA Kits, Anti-Myoglobin Detection Kit, Myoglobin Ria Test Kit, ...
Biotech Atlantic, Inc. develops and manufactures diagnostic kits & related life science products. We offer products like fertility, drug abuse, infectious disease, sexually transmitted disease & marke more...
EMD Chemicals, Inc. | Address: 480 South Democrat Road, Gibbstown, New Jersey 08027, USA
www.emdchemicals.com | Send Inquiry | Phone: +1-(856)-423-6300, 800-222-0342
FDA Registration: 9610140 Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~700 Quality: ISO 9001 Certified
Products: Slide Stainers, Stainers, Automated Slide Stainer (FDA Code: KPA), Programmable Slide Stainers, Cytology Equipment Stainers, Hematology Slide Stainer Instruments, ...
EMD Chemicals, Inc. offers an array of reagents, used worldwide in disease-related life sciences research at pharmaceutical and biotechnology companies. Our optics division of our chemicals gives chem more...
www.emdchemicals.com | Send Inquiry | Phone: +1-(856)-423-6300, 800-222-0342
FDA Registration: 9610140 Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~700 Quality: ISO 9001 Certified
Products: Slide Stainers, Stainers, Automated Slide Stainer (FDA Code: KPA), Programmable Slide Stainers, Cytology Equipment Stainers, Hematology Slide Stainer Instruments, ...
EMD Chemicals, Inc. offers an array of reagents, used worldwide in disease-related life sciences research at pharmaceutical and biotechnology companies. Our optics division of our chemicals gives chem more...
Labchem Inc. | Address: 200 William Pitt Way, Pittsburgh, Pennsylvania 15238, USA
www.labchem.net | Send Inquiry | Phone: +1-(412)-826-5230
FDA Registration: 2523642 Year Established: 1986 Employee Count: ~40 Quality: ISO 9001 Certified
Products: General Examination Supplies, Buffer Solution, pH Buffer (FDA Code: JCC), Water Based Hematology Stainer, pH Buffer Calibration Solutions, Eosin Y Stain (FDA Code: HYB), ...
Labchem Inc. produces aqueous solutions prepared to exact quality standards and certified for use in laboratories performing specified standard methods of analysis. We are accredited with ISO 9001:200 more...
www.labchem.net | Send Inquiry | Phone: +1-(412)-826-5230
FDA Registration: 2523642 Year Established: 1986 Employee Count: ~40 Quality: ISO 9001 Certified
Products: General Examination Supplies, Buffer Solution, pH Buffer (FDA Code: JCC), Water Based Hematology Stainer, pH Buffer Calibration Solutions, Eosin Y Stain (FDA Code: HYB), ...
Labchem Inc. produces aqueous solutions prepared to exact quality standards and certified for use in laboratories performing specified standard methods of analysis. We are accredited with ISO 9001:200 more...
Stanbio Laboratory | Address: 1261,North Main Street, Boerne, Texas 78006, USA
www.stanbio.com | Send Inquiry | Phone: +1-(830)-249-0772
FDA Registration: 1616487 Year Established: 1960 Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 9001 Certified
Products: Hemoglobin Testing Systems, Alkaline Phosphatase (ALP) (FDA Code: JCJ), Hemoglobin Analyzers, Streptococcus Test Kits, Coagulation Lab Testing, Infectious Disease Exams, ...
Stanbio Laboratory is a developer, manufacturer and distributor clinical diagnostic products. Our UriTrak™ 100 analyzer is an economical system that offers physician offices & laboratories the a more...
www.stanbio.com | Send Inquiry | Phone: +1-(830)-249-0772
FDA Registration: 1616487 Year Established: 1960 Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 9001 Certified
Products: Hemoglobin Testing Systems, Alkaline Phosphatase (ALP) (FDA Code: JCJ), Hemoglobin Analyzers, Streptococcus Test Kits, Coagulation Lab Testing, Infectious Disease Exams, ...
Stanbio Laboratory is a developer, manufacturer and distributor clinical diagnostic products. Our UriTrak™ 100 analyzer is an economical system that offers physician offices & laboratories the a more...
Volu-sol, Inc. | Address: 5095 West 2100 South, Salt Lake City, Utah 84120, USA
www.volusol.com | Send Inquiry | Phone: +1-(801)-974-9474, 800-821-2495
Annual Revenues: USD 1-5 Million
Products: Slide Stainers, Slide Staining, Controls for Diagnostic Equipment, General Diagnostic Supplies, General Medical Supplies, Stain Sets & Solutions, ...
Volu-sol, Inc. provides medical stains and reagents to laboratories & clinics to assist in the examination of blood & other bodily tissues & fluids. We sell several stains, kits, solutions and other c more...
www.volusol.com | Send Inquiry | Phone: +1-(801)-974-9474, 800-821-2495
Annual Revenues: USD 1-5 Million
Products: Slide Stainers, Slide Staining, Controls for Diagnostic Equipment, General Diagnostic Supplies, General Medical Supplies, Stain Sets & Solutions, ...
Volu-sol, Inc. provides medical stains and reagents to laboratories & clinics to assist in the examination of blood & other bodily tissues & fluids. We sell several stains, kits, solutions and other c 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: Myoglobin (FDA Code: DDR), Ferritin (FDA Code: DBF), Anti-acetylcholine Receptor Alpha Monoclonal Antibody, Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Slide Stainer (FDA Code: KPA), Microscope Slides (FDA Code: KEW), ...
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: Myoglobin (FDA Code: DDR), Ferritin (FDA Code: DBF), Anti-acetylcholine Receptor Alpha Monoclonal Antibody, Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Slide Stainer (FDA Code: KPA), Microscope Slides (FDA Code: KEW), ...
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: Tissue Forceps, Stitch Scissors, Suture Needles, Surgical Scissors, Microscope Slide Staining Kit, Microscope Slide Dispenser, ...
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: Tissue Forceps, Stitch Scissors, Suture Needles, Surgical Scissors, Microscope Slide Staining Kit, Microscope Slide Dispenser, ...
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, Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Slide Stainer (FDA Code: KPA), Automated Tissue Processor (FDA Code: IEO), Imaging Systems, ...
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, Analyte Specific Reagents, Asr Reagents (FDA Code: MVU), Automated Slide Stainer (FDA Code: KPA), Automated Tissue Processor (FDA Code: IEO), Imaging Systems, ...
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...
Medical Chemical Corporation | Address: 19430 Van Ness Avenue, Torrance, California 90501, USA
www.med-chem.com | Send Inquiry | Phone: +1-(310)-787-6800, 800-424-9394
FDA Registration: 2013736 Year Established: 1954 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Antiseptics, Disinfectants & Germicides, Instant Hand Sanitizers, Laboratory Reagent, Deodorizers, Testing Strips, ...
Medical Chemical Corporation provides a wide range of medical chemical solutions. Our product list comprises of laboratory reagents & stains, soaps, germicides, cold sterilants, alcohols as well as va more...
www.med-chem.com | Send Inquiry | Phone: +1-(310)-787-6800, 800-424-9394
FDA Registration: 2013736 Year Established: 1954 Annual Revenues: USD 1-5 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Antiseptics, Disinfectants & Germicides, Instant Hand Sanitizers, Laboratory Reagent, Deodorizers, Testing Strips, ...
Medical Chemical Corporation provides a wide range of medical chemical solutions. Our product list comprises of laboratory reagents & stains, soaps, germicides, cold sterilants, alcohols as well as va more...
Rocky Mountain Reagents,Inc. | Address: 3207 W. Hampden Avenue, Englewood, Colorado 80110-3261, USA
www.rmreagents.com | Send Inquiry | Phone: +1-(303)-762-0800
FDA Registration: 1711690 Annual Revenues: < USD 1 Million Employee Count: ~10
Products: Laboratory Glassware, Glassware, Packaging, Laboratory Pipetting kit, Eosin Y Stain (FDA Code: HYB), Laboratory Beaker, ...
Rocky Mountain Reagents, Inc. provides laboratory reagents, chemicals and supplies for industries such as clinical, analytical & research. We also offer labware such as beakers, cylinders, flasks, pip more...
www.rmreagents.com | Send Inquiry | Phone: +1-(303)-762-0800
FDA Registration: 1711690 Annual Revenues: < USD 1 Million Employee Count: ~10
Products: Laboratory Glassware, Glassware, Packaging, Laboratory Pipetting kit, Eosin Y Stain (FDA Code: HYB), Laboratory Beaker, ...
Rocky Mountain Reagents, Inc. provides laboratory reagents, chemicals and supplies for industries such as clinical, analytical & research. We also offer labware such as beakers, cylinders, flasks, pip more...
EK Industries, Inc. | Address: 1403 Herkimer Street, Joliet, Illinois 60432, USA
www.eki-chem.com | Send Inquiry | Phone: +1-(815)-723-4000
FDA Registration: 1419699 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO Certified
Products: Chemical Supplies, Chemistry Analyzers, Disinfect & Cleaning Solution, Hematology Reagents, IV Fluids, Microbiology Kit, ...
EK Industries, Inc. produces chemicals & reagents for use in the clinical/medical laboratory, as well as the industrial testing laboratory. We offer custom formulation, contract packaging, private lab more...
www.eki-chem.com | Send Inquiry | Phone: +1-(815)-723-4000
FDA Registration: 1419699 Year Established: 1976 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO Certified
Products: Chemical Supplies, Chemistry Analyzers, Disinfect & Cleaning Solution, Hematology Reagents, IV Fluids, Microbiology Kit, ...
EK Industries, Inc. produces chemicals & reagents for use in the clinical/medical laboratory, as well as the industrial testing laboratory. We offer custom formulation, contract packaging, private lab 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, Hematoxylin Stain (FDA Code: HYJ), Eosin Y Stain (FDA Code: HYB), Isotonic Solution (FDA Code: JCE), Hematology Stain (FDA Code: KQC), ...
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, Hematoxylin Stain (FDA Code: HYJ), Eosin Y Stain (FDA Code: HYB), Isotonic Solution (FDA Code: JCE), Hematology Stain (FDA Code: KQC), ...
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...
Rowley Biochemical Inc. | Address: 10 Electronics Avenue, Danvers, Massachusetts 01923, USA
www.rowleybio.com | Send Inquiry | Phone: +1-(978)-739-4883
FDA Registration: 1219125 Annual Revenues: < USD 1 Million
Products: Chemical Supplies, General Medical Supplies, General Diagnostics, General Examination Supplies, Stain Sets & Solutions, Eosin Y Stain (FDA Code: HYB), ...
Rowley Biochemical Inc. supplies biochemical research facilities, university and clinical laboratories with quality in-vitro stains and reagents. We offer quality dyes, stains & biochemical reagents r more...
www.rowleybio.com | Send Inquiry | Phone: +1-(978)-739-4883
FDA Registration: 1219125 Annual Revenues: < USD 1 Million
Products: Chemical Supplies, General Medical Supplies, General Diagnostics, General Examination Supplies, Stain Sets & Solutions, Eosin Y Stain (FDA Code: HYB), ...
Rowley Biochemical Inc. supplies biochemical research facilities, university and clinical laboratories with quality in-vitro stains and reagents. We offer quality dyes, stains & biochemical reagents r 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...
A. J. P. Scientific, Inc. | Address: 82 Industrial East, Clifton, New Jersey 07012, USA
www.engscientific.com | Send Inquiry | Phone: +1-(973)-472-7200
FDA Registration: 2250039
Products: Stainers, Male Fertility Testing, Semen Analyzers, Reagents, Urinary Sediment Stain, Heinz Body Stain (FDA Code: GJJ), Hematology Giemsa Stain, ...
A. J. P. Scientific, Inc. is a provider of stains and reagents utilized by clinical laboratories, hospitals, doctor's offices and private clinics. We offer stains for use in hematology, urology, blood more...
www.engscientific.com | Send Inquiry | Phone: +1-(973)-472-7200
FDA Registration: 2250039
Products: Stainers, Male Fertility Testing, Semen Analyzers, Reagents, Urinary Sediment Stain, Heinz Body Stain (FDA Code: GJJ), Hematology Giemsa Stain, ...
A. J. P. Scientific, Inc. is a provider of stains and reagents utilized by clinical laboratories, hospitals, doctor's offices and private clinics. We offer stains for use in hematology, urology, blood more...
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FDA Code / Regulation: HYF / 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.
