FDA product code GTX: Antisera, Fluorescent, All Groups, Streptococcus Spp.
GTX is the FDA product code for antisera, fluorescent, all groups, streptococcus spp.. It is a Class I device, regulated under 21 CFR 866.3740 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under GTX, from 2 different applicants. The average 510(k) review took 26 days (median 26).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, All Groups, Streptococcus Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3740 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GTX clearance
Top GTX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Springwood Microbiologicals | 1 | 1981-07-28 |
| Clinical Sciences, Inc. | 1 | 1980-09-16 |
Most recent GTX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K812013 | Springwood Microbiologicals | FLUORESCENT ANTIBODY CONJUGATE FOR GP.A | 1981-07-28 | 11 |
| K801876 | Clinical Sciences, Inc. | STREP B POLYVALENT FLUORO-KIT | 1980-09-16 | 42 |
Recalls for GTX devices
openFDA lists no recalls for product code GTX.
Frequently asked questions
What is FDA product code GTX?
GTX is the FDA product code for antisera, fluorescent, all groups, streptococcus spp.. It is a Class I device, regulated under 21 CFR 866.3740 and reviewed by the Microbiology panel.
What device class is GTX?
Class I, regulation 21 CFR 866.3740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GTX?
Across 2 cleared submissions the average was 26 days from receipt to decision (median 26).
Which companies have the most GTX clearances?
Springwood Microbiologicals (1); Clinical Sciences, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GTX
- Run a recall and safety report across every GTX manufacturer
- Watch product code GTX 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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