Giemsa Stain
Giemsa stain is a polychromatic histological and hematological staining reagent used to differentially stain blood cells, bone marrow cells, and microorganisms including parasites such as malaria, as well as chromosomes in cytogenetic preparations. It is classified as an FDA Class 1 device under 21 CFR 864.1850, indicating minimal risk and general controls. Product code HYF falls under the Hematology medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
Basic Information
- Product Code
- HYF
- Device Class
- FDA class 1
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K842742 | GIEMSA STAIN | Aug 15, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K833677 | QUICK STAIN WRIGHT'S GIEMSA W/BUFF | Nov 25, 1983 | Substantially Equivalent | J.S. Medical Assoc. |
| K833665 | HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK | Nov 25, 1983 | Substantially Equivalent | J.S. Medical Assoc. |
| K831131 | CASE WRIGHT-GIEMSA STAIN PAK | Jun 08, 1983 | Substantially Equivalent | Case Instruments |
FEI Numbers
This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.