FDA product code GNP: Antiserum, Cf, Epstein-Barr Virus
GNP is the FDA product code for antiserum, cf, epstein-barr virus. It is a Class I device, regulated under 21 CFR 866.3235 and reviewed by the Microbiology panel. FDA has cleared 20 510(k) submissions under GNP, from 13 different applicants. The average 510(k) review took 188 days (median 175). FDA has posted 2 recalls for GNP devices.
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Cf, Epstein-Barr Virus |
| Device class | Class I |
| Regulation | 21 CFR 866.3235 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GNP clearance
Top GNP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pan Bio Pty. , Ltd. | 3 | 2002-06-13 |
| Diamedix Corp. | 2 | 1999-02-16 |
| Granbio, Inc. | 2 | 1990-09-12 |
| Immuno Concepts, Inc. | 2 | 1988-08-30 |
| Diagnostic Technology, Inc. | 2 | 1987-06-25 |
8 more applicants have GNP clearances. See the full list in Caduvo.
Most recent GNP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K020717 | Pan Bio Pty. , Ltd. | EBV V VCA IGM ELISA KIT MODEL# EBM-200 | 2002-06-13 | 100 |
| K020707 | Pan Bio Pty. , Ltd. | EBV-EBNA IGG ELISA KIT, MODEL EBG-100 | 2002-06-13 | 101 |
| K020706 | Pan Bio Pty. , Ltd. | EBV-VCA IGG ELISA TEST, MODEL EBG-100 | 2002-06-13 | 101 |
| K981829 | Diamedix Corp. | IS EBV-EBNA-1 IGG ELISA TEST SYSTEM | 1999-02-16 | 270 |
| K981831 | Diamedix Corp. | IS EBV-EA-D IGG ELISA TEST SYSTEM | 1999-02-16 | 270 |
Recalls for GNP devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-01-05.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code GNP?
GNP is the FDA product code for antiserum, cf, epstein-barr virus. It is a Class I device, regulated under 21 CFR 866.3235 and reviewed by the Microbiology panel.
What device class is GNP?
Class I, regulation 21 CFR 866.3235. Typical premarket route: 510(k).
How long does a 510(k) take for product code GNP?
Across 20 cleared submissions the average was 188 days from receipt to decision (median 175).
Which companies have the most GNP clearances?
Pan Bio Pty. , Ltd. (3); Diamedix Corp. (2); Granbio, Inc. (2); Immuno Concepts, Inc. (2); Diagnostic Technology, Inc. (2).
Have GNP devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2018-01-05.
Next steps
- Run an FDA pathway report with predicate devices for product code GNP
- Run a recall and safety report across every GNP manufacturer
- Watch product code GNP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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