GRZClass I
Antisera, Fluorescent, All, Mycoplasma Spp.
21 CFR 866.3375 / Microbiology
GRZ is the FDA product code for Antisera, Fluorescent, All, Mycoplasma Spp., a class I device type, regulated under 21 CFR 866.3375. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- GRZ
- Device name
- Antisera, Fluorescent, All, Mycoplasma Spp.
- Regulation
- 21 CFR 866.3375
- Device class
- Class I
- Review panel
- Microbiology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 5
- Ingested recalls
- 0
Clearances, product code GRZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1986 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 1 |
Applicants with the most clearances
Product code GRZ| Applicant | Clearances |
|---|---|
| Zeus Scientific LLC | 2 |
| Fuller Laboratories, Inc. | 1 |
| Whittaker Bioproducts, Inc. | 1 |
| Zeus Technologies | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code GRZ.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
