Wright's Stain Suppliers
Limit companies to: Worldwide USA
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...
Sysmex America, Inc. | Address: One Nelson C. White Parkway, Mundelein, Illinois 60060, USA
www.sysmex.com | Send Inquiry | Phone: +1-(847)-996-4500, 800-379-7639
FDA Registration: 1422681
Products: Hematology Analyzers, Coagulation Analyzers (FDA Code: GKP), Particle and Cell Urinalysis Systems, Controls, General Diagnostic Supplies, General Diagnostics, ...
Sysmex America, Inc. manufactures and markets clinical laboratory testing devices, reagents, and software for hematology, hemostasis, immuno-chemistry, particle counting and urinalysis and also distri more...
www.sysmex.com | Send Inquiry | Phone: +1-(847)-996-4500, 800-379-7639
FDA Registration: 1422681
Products: Hematology Analyzers, Coagulation Analyzers (FDA Code: GKP), Particle and Cell Urinalysis Systems, Controls, General Diagnostic Supplies, General Diagnostics, ...
Sysmex America, Inc. manufactures and markets clinical laboratory testing devices, reagents, and software for hematology, hemostasis, immuno-chemistry, particle counting and urinalysis and also distri 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...
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: Hypodermic Needles, Hypodermic Syringes, Colony Counters, Slide Staining, Gastroenterologic Needle Holder (FDA Code: FHQ), Iris Scissors, ...
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: Hypodermic Needles, Hypodermic Syringes, Colony Counters, Slide Staining, Gastroenterologic Needle Holder (FDA Code: FHQ), Iris Scissors, ...
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...
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...
DRG International, Inc. | Address: 1167 US Highway 22 East, Mountainside, New Jersey 07092, USA
www.drg-international.com | Send Inquiry | Phone: +1-(908)-233-2075
FDA Registration: 2245285 Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9000, ISO 9001, CE Certified
Products: Laboratory Equipment, Incubators, Amylase, Incubator Shakers, Angiotensin II, Lyme Disease (Borrelia) Test Kits, ...
DRG International, Inc. is a multinational specialty medical equipment and diagnostics manufacturer & distributor. We offer products for enzyme immunoassays, rapid saliva & tumor tests, radio immunoas more...
www.drg-international.com | Send Inquiry | Phone: +1-(908)-233-2075
FDA Registration: 2245285 Year Established: 1970 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9000, ISO 9001, CE Certified
Products: Laboratory Equipment, Incubators, Amylase, Incubator Shakers, Angiotensin II, Lyme Disease (Borrelia) Test Kits, ...
DRG International, Inc. is a multinational specialty medical equipment and diagnostics manufacturer & distributor. We offer products for enzyme immunoassays, rapid saliva & tumor tests, radio immunoas 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...
Beckman Coulter, Inc. | Address: 4300 N. Harbor Boulevard P.O. Box 3100, Fullerton, California 92834-3100, USA
www.coulter.com | Phone: +001-(800)-742-2345
FDA Registration: 2050012 Year Established: 1934 Annual Revenues: > USD 1 Billion Employee Count: ~10100 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Blood Glucose Meters, Blood Pressure Measuring Equipment, Fetal Monitors, Otoscopes, Blood Bags For Dialysis, Blood & Intravenous (IV) Bottles, ...
Beckman Coulter, Inc. is a manufacturer of biomedical testing instrument systems, tests & supplies that simplify and automate laboratory processes. Spanning the biomedical testing continuum from medic more...
www.coulter.com | Phone: +001-(800)-742-2345
FDA Registration: 2050012 Year Established: 1934 Annual Revenues: > USD 1 Billion Employee Count: ~10100 Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Blood Glucose Meters, Blood Pressure Measuring Equipment, Fetal Monitors, Otoscopes, Blood Bags For Dialysis, Blood & Intravenous (IV) Bottles, ...
Beckman Coulter, Inc. is a manufacturer of biomedical testing instrument systems, tests & supplies that simplify and automate laboratory processes. Spanning the biomedical testing continuum from medic 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...
Cambridge Diagnostic Products, Inc. | Address: 6880 N.W. 17th Avenue, Fort Lauderdale, Florida 33309-1524, USA
www.ecamco.com | Send Inquiry | Phone: +1-(954)-971-4040, 800-525-6262
FDA Registration: 1029182 Year Established: 1953 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: ISO Certified
Products: Hematology Stain (FDA Code: KQC), Hematology Giemsa Stain, Hematology Wright's Stain, Alcohol Containing Fixative (FDA Code: LDZ), Chemical Solution Stain (FDA Code: LED), General Purpose Reagent (FDA Code: LDT), ...
Cambridge Diagnostic Products, Inc. is a provider of buffered differential hematology stain products. Our product lines are urinary sediment, anticoagulants, fecal occult blood determination, strain r more...
www.ecamco.com | Send Inquiry | Phone: +1-(954)-971-4040, 800-525-6262
FDA Registration: 1029182 Year Established: 1953 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: ISO Certified
Products: Hematology Stain (FDA Code: KQC), Hematology Giemsa Stain, Hematology Wright's Stain, Alcohol Containing Fixative (FDA Code: LDZ), Chemical Solution Stain (FDA Code: LED), General Purpose Reagent (FDA Code: LDT), ...
Cambridge Diagnostic Products, Inc. is a provider of buffered differential hematology stain products. Our product lines are urinary sediment, anticoagulants, fecal occult blood determination, strain r 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...
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: Forceps (FDA Code: HTD), Sutures, Disposables, Needles, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Smoke Evacuators, ...
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: Forceps (FDA Code: HTD), Sutures, Disposables, Needles, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Smoke Evacuators, ...
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, 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...
Pochemco, Inc. | Address: 724 Main Street, Holyoke, Massachusetts 01040, USA
Phone: +1-(413)-536-2900
Year Established: 1969 Annual Revenues: < USD 1 Million
Products: Fertility Products, Isotonic Solution, pH Buffer (FDA Code: JCC), pH Buffer Calibration Solutions, Eosin Y Stain (FDA Code: HYB), Chromatographic Barbiturate Identification Test (FDA Code: DKX), Manual Platelet Counter (FDA Code: GLG), ...
Pochemco, Inc. offers chromatographic barbiturate identification test, Wright's stain, microbiological stains, and white blood cell diluting fluids. more...
Phone: +1-(413)-536-2900
Year Established: 1969 Annual Revenues: < USD 1 Million
Products: Fertility Products, Isotonic Solution, pH Buffer (FDA Code: JCC), pH Buffer Calibration Solutions, Eosin Y Stain (FDA Code: HYB), Chromatographic Barbiturate Identification Test (FDA Code: DKX), Manual Platelet Counter (FDA Code: GLG), ...
Pochemco, Inc. offers chromatographic barbiturate identification test, Wright's stain, microbiological stains, and white blood cell diluting fluids. 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...
Mallinckrodt Baker, Inc. | Address: 222 Red School Lane, Phillipsburg, New Jersey 08865, USA
www.mallbaker.com | Phone: +1-(908)-859-2151
FDA Registration: 1045125 Year Established: 1995
Products: Basic Fuchsin Counter Stain, Hematoxylin Stain (FDA Code: HYJ), Hematoxylin Stain Solution with Phosphotungstic Acid, Eosin Y Stain (FDA Code: HYB), Basic Fuchsin (FDA Code: KKW), Hematology Stain (FDA Code: KQC), ...
Mallinckrodt Baker, Inc. is a chemical company that offers products for laboratory and biopharmaceutical markets. We are suppliers of bulk pharmaceutical excipients, GMP manufactured aqueous solutions more...
www.mallbaker.com | Phone: +1-(908)-859-2151
FDA Registration: 1045125 Year Established: 1995
Products: Basic Fuchsin Counter Stain, Hematoxylin Stain (FDA Code: HYJ), Hematoxylin Stain Solution with Phosphotungstic Acid, Eosin Y Stain (FDA Code: HYB), Basic Fuchsin (FDA Code: KKW), Hematology Stain (FDA Code: KQC), ...
Mallinckrodt Baker, Inc. is a chemical company that offers products for laboratory and biopharmaceutical markets. We are suppliers of bulk pharmaceutical excipients, GMP manufactured aqueous solutions more...
Poly Scientific | Address: 70 Cleveland Ave., Bay Shore, New York 11706, USA
www.polyrnd.com | Send Inquiry | Phone: +1-(631)-586-0400, 800-645-5825
FDA Registration: 2429783 Year Established: 1969 Employee Count: ~40
Products: Cytology Test Kits, Medicine Cups, Buffer Solution, Water Based Hematology Stainer, Stainless Steel Medicine Cup, Hematoxylin Stain (FDA Code: HYJ), ...
Poly Scientific manufactures chemicals, stains and reagents for histology, cytology, microbiology, in-vitro diagnostic testing in hospitals, laboratories, & pharmaceutical companies. Our product categ more...
www.polyrnd.com | Send Inquiry | Phone: +1-(631)-586-0400, 800-645-5825
FDA Registration: 2429783 Year Established: 1969 Employee Count: ~40
Products: Cytology Test Kits, Medicine Cups, Buffer Solution, Water Based Hematology Stainer, Stainless Steel Medicine Cup, Hematoxylin Stain (FDA Code: HYJ), ...
Poly Scientific manufactures chemicals, stains and reagents for histology, cytology, microbiology, in-vitro diagnostic testing in hospitals, laboratories, & pharmaceutical companies. Our product categ more...
Sponsored Links
FDA Code / Regulation: IAF / 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.
