FDA product code GOI: Antiserum, Fluorescent, Rabies Virus
GOI is the FDA product code for antiserum, fluorescent, rabies virus. It is a Class II device, regulated under 21 CFR 866.3460 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under GOI, from 2 different applicants. The average 510(k) review took 275 days (median 275).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Fluorescent, Rabies Virus |
| Device class | Class II |
| Regulation | 21 CFR 866.3460 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every GOI clearance
Top GOI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Light Diagnostics | 1 | 1998-12-22 |
| Centocor, Inc. | 1 | 1982-04-16 |
Most recent GOI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972975 | Light Diagnostics | LIGHT DIAGNOSTICS RABIES DFA REAGENT | 1998-12-22 | 498 |
| K820499 | Centocor, Inc. | FITC ANTI-RABIES MONOCLONAL GLOBULIN | 1982-04-16 | 52 |
Recalls for GOI devices
openFDA lists no recalls for product code GOI.
Frequently asked questions
What is FDA product code GOI?
GOI is the FDA product code for antiserum, fluorescent, rabies virus. It is a Class II device, regulated under 21 CFR 866.3460 and reviewed by the Microbiology panel.
What device class is GOI?
Class II, regulation 21 CFR 866.3460. Typical premarket route: 510(k).
How long does a 510(k) take for product code GOI?
Across 2 cleared submissions the average was 275 days from receipt to decision (median 275).
Which companies have the most GOI clearances?
Light Diagnostics (1); Centocor, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GOI
- Run a recall and safety report across every GOI manufacturer
- Watch product code GOI 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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