FDA product code GTZ: Antisera, All Groups, Streptococcus Spp.
GTZ is the FDA product code for antisera, 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 105 510(k) submissions under GTZ, from 52 different applicants. The average 510(k) review took 106 days (median 68). FDA has posted 3 recalls for GTZ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, 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 GTZ clearance
Top GTZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 9 | 1998-03-03 |
| Quidel Corp. | 8 | 1996-04-15 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 7 | 1995-10-20 |
| Binax, Inc. | 6 | 2001-11-30 |
| Diagnostic Products Corp. | 4 | 1990-05-21 |
47 more applicants have GTZ clearances. See the full list in Caduvo.
Most recent GTZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K012521 | Binax, Inc. | BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST | 2001-11-30 | 116 |
| K011709 | Trinity Biotech, Plc | UNI-GOLD STREP A TEST KIT | 2001-11-08 | 157 |
| K010523 | Binax, Inc. | MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST | 2001-03-15 | 21 |
| K991726 | Binax, Inc. | BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI | 1999-08-27 | 99 |
| K971522 | Abbott Laboratories | ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II | 1998-03-03 | 312 |
Recalls for GTZ devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-08-20.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code GTZ?
GTZ is the FDA product code for antisera, 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 GTZ?
Class I, regulation 21 CFR 866.3740. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GTZ?
Across 105 cleared submissions the average was 106 days from receipt to decision (median 68).
Which companies have the most GTZ clearances?
Abbott Laboratories (9); Quidel Corp. (8); Bd Becton Dickinson Vacutainer Systems Preanalytic (7); Binax, Inc. (6); Diagnostic Products Corp. (4).
Have GTZ devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2024-08-20.
Next steps
- Run an FDA pathway report with predicate devices for product code GTZ
- Run a recall and safety report across every GTZ manufacturer
- Watch product code GTZ 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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