FDA product code NBT: Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
NBT is the FDA product code for antibodies, saccharomyces cerevisiae (s.cerevisiae). It is a Class II device, regulated under 21 CFR 866.5785 and reviewed by the Immunology panel. FDA has cleared 7 510(k) submissions under NBT, from 6 different applicants. The average 510(k) review took 241 days (median 188). 1 De Novo request was granted under it.
Classification
| Field | Value |
|---|---|
| Device name | Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) |
| Device class | Class II |
| Regulation | 21 CFR 866.5785 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NBT clearance
Top NBT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immco Diagnostics, Inc. | 2 | 2004-03-18 |
| Techlab Inc., Corporate Research Center | 1 | 2007-11-07 |
| Techlab, Inc. | 1 | 2006-04-06 |
| Aesku, Inc. | 1 | 2005-11-14 |
| The Binding Site | 1 | 2005-07-28 |
1 more applicants have NBT clearances. See the full list in Caduvo.
Most recent NBT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K071711 | Techlab Inc., Corporate Research Center | ASCA-CHEK | 2007-11-07 | 138 |
| K051927 | Techlab, Inc. | TECHLAB ASCA-CHEK | 2006-04-06 | 262 |
| K051492 | Aesku, Inc. | AESKULISA ASCA A | 2005-11-14 | 161 |
| K042579 | The Binding Site | BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT | 2005-07-28 | 309 |
| K032860 | Immco Diagnostics, Inc. | IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) | 2004-03-18 | 188 |
Recalls for NBT devices
openFDA lists no recalls for product code NBT.
Frequently asked questions
What is FDA product code NBT?
NBT is the FDA product code for antibodies, saccharomyces cerevisiae (s.cerevisiae). It is a Class II device, regulated under 21 CFR 866.5785 and reviewed by the Immunology panel.
What device class is NBT?
Class II, regulation 21 CFR 866.5785. Typical premarket route: 510(k).
How long does a 510(k) take for product code NBT?
Across 7 cleared submissions the average was 241 days from receipt to decision (median 188).
Which companies have the most NBT clearances?
Immco Diagnostics, Inc. (2); Techlab Inc., Corporate Research Center (1); Techlab, Inc. (1); Aesku, Inc. (1); The Binding Site (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NBT
- Run a recall and safety report across every NBT manufacturer
- Watch product code NBT 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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