GPFClass I
Antigen, Agglutinating, Echinococcus Spp.
21 CFR 866.3200 / Microbiology
GPF is the FDA product code for Antigen, Agglutinating, Echinococcus Spp., a class I device type, regulated under 21 CFR 866.3200. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- GPF
- Device name
- Antigen, Agglutinating, Echinococcus Spp.
- Regulation
- 21 CFR 866.3200
- 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
- 1
- Ingested recalls
- 0
Clearances, product code GPF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
Applicants with the most clearances
Product code GPF| Applicant | Clearances |
|---|---|
| Volu Sol Medical Industries | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- American Laboratory Products Company
- Bordier Affinity Products SA
- DEMEDITEC DIAGNOSTICS GmbH
- Diagnostic Automation/ Cortez Diagnostics Inc.
- Diesse Diagnostica Senese S.P.A
- DRG Instruments GmbH
- DRG International, Inc.
- Eiger Diagnostics, Inc.
- Gold Standard Diagnostics Frankfurt GmbH
- Gold Standard Diagnostics, LLC
- Immuno-Biological Laboratories, Inc.
- New Life Diagnostics Inc.
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