FDA product code GRP: Antisera, All Types, H. Influenza
GRP is the FDA product code for antisera, all types, h. influenza. It is a Class II device, regulated under 21 CFR 866.3300 and reviewed by the Microbiology panel. FDA has cleared 6 510(k) submissions under GRP, from 6 different applicants. The average 510(k) review took 63 days (median 47). FDA has posted 1 recall for GRP devices.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, All Types, H. Influenza |
| Device class | Class II |
| Regulation | 21 CFR 866.3300 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GRP clearance
Top GRP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Armkel, LLC | 1 | 1989-02-07 |
| American Micro Scan | 1 | 1985-12-27 |
| Seragen Diagnostics, Inc. | 1 | 1983-09-29 |
| Diagnostica, Inc. | 1 | 1982-12-28 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1982-06-01 |
1 more applicants have GRP clearances. See the full list in Caduvo.
Most recent GRP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884967 | Armkel, LLC | BACTIGEN(R) H. INFLUENZAE TYPE B | 1989-02-07 | 69 |
| K854490 | American Micro Scan | IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES | 1985-12-27 | 45 |
| K831525 | Seragen Diagnostics, Inc. | H-FLU B ELISA TEST | 1983-09-29 | 140 |
| K823348 | Diagnostica, Inc. | H. INFLUENZA B ANTISERA FOR CIE | 1982-12-28 | 49 |
| K821266 | Bd Becton Dickinson Vacutainer Systems Preanalytic | BBL DIRECTIGEN MENINGITIS TEST KIT | 1982-06-01 | 29 |
Recalls for GRP devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-08-12.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code GRP?
GRP is the FDA product code for antisera, all types, h. influenza. It is a Class II device, regulated under 21 CFR 866.3300 and reviewed by the Microbiology panel.
What device class is GRP?
Class II, regulation 21 CFR 866.3300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GRP?
Across 6 cleared submissions the average was 63 days from receipt to decision (median 47).
Which companies have the most GRP clearances?
Armkel, LLC (1); American Micro Scan (1); Seragen Diagnostics, Inc. (1); Diagnostica, Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Have GRP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-08-12.
Next steps
- Run an FDA pathway report with predicate devices for product code GRP
- Run a recall and safety report across every GRP manufacturer
- Watch product code GRP 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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