FDA product code GOD: Antigens, Cf (Including Cf Control), Adenovirus 1-33
GOD is the FDA product code for antigens, cf (including cf control), adenovirus 1-33. It is a Class I device, regulated under 21 CFR 866.3020 and reviewed by the Microbiology panel. FDA has cleared 11 510(k) submissions under GOD, from 8 different applicants. The average 510(k) review took 153 days (median 174). FDA has posted 1 recall for GOD devices.
Classification
| Field | Value |
|---|---|
| Device name | Antigens, Cf (Including Cf Control), Adenovirus 1-33 |
| Device class | Class I |
| Regulation | 21 CFR 866.3020 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GOD clearance
Top GOD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cambridge Bioscience Corp. | 3 | 1988-07-08 |
| Orion Diagnostica, Inc. | 2 | 1987-06-04 |
| Rapid Pathogen Screening, Inc. | 1 | 2011-05-17 |
| Rapid Pathogen Screening | 1 | 2005-11-22 |
| Sa Scientific, Inc. | 1 | 1999-08-19 |
3 more applicants have GOD clearances. See the full list in Caduvo.
Most recent GOD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K110722 | Rapid Pathogen Screening, Inc. | RPS ADENO DETECTOR PLUS | 2011-05-17 | 63 |
| K052092 | Rapid Pathogen Screening | RPS ADENO DETECTOR | 2005-11-22 | 112 |
| K990630 | Sa Scientific, Inc. | SAS ADENO TEST | 1999-08-19 | 174 |
| K972406 | Immunoprobe, Inc. | ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM | 1997-12-22 | 179 |
| K881894 | Cambridge Bioscience Corp. | ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) | 1988-07-08 | 64 |
Recalls for GOD devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-05-05.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code GOD?
GOD is the FDA product code for antigens, cf (including cf control), adenovirus 1-33. It is a Class I device, regulated under 21 CFR 866.3020 and reviewed by the Microbiology panel.
What device class is GOD?
Class I, regulation 21 CFR 866.3020. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GOD?
Across 11 cleared submissions the average was 153 days from receipt to decision (median 174).
Which companies have the most GOD clearances?
Cambridge Bioscience Corp. (3); Orion Diagnostica, Inc. (2); Rapid Pathogen Screening, Inc. (1); Rapid Pathogen Screening (1); Sa Scientific, Inc. (1).
Have GOD devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-05-05.
Next steps
- Run an FDA pathway report with predicate devices for product code GOD
- Run a recall and safety report across every GOD manufacturer
- Watch product code GOD 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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