FDA product code GTI: Antisera, Fluorescent, All Groups, N. Meningitidis
GTI is the FDA product code for antisera, fluorescent, all groups, n. meningitidis. It is a Class II device, regulated under 21 CFR 866.3390 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under GTI. The average 510(k) review took 44 days (median 44).
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, All Groups, N. Meningitidis |
| Device class | Class II |
| Regulation | 21 CFR 866.3390 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GTI clearance
Top GTI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 1992-03-18 |
Most recent GTI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920274 | Bd Becton Dickinson Vacutainer Systems Preanalytic | DIRECTIGEN NEISSERIA MENINGITIDIS TEST | 1992-03-18 | 56 |
| K841308 | Bd Becton Dickinson Vacutainer Systems Preanalytic | DIRECTIGEN MENNINGITIS TEST KIT | 1984-05-02 | 33 |
Recalls for GTI devices
openFDA lists no recalls for product code GTI.
Frequently asked questions
What is FDA product code GTI?
GTI is the FDA product code for antisera, fluorescent, all groups, n. meningitidis. It is a Class II device, regulated under 21 CFR 866.3390 and reviewed by the Microbiology panel.
What device class is GTI?
Class II, regulation 21 CFR 866.3390. Typical premarket route: 510(k).
How long does a 510(k) take for product code GTI?
Across 2 cleared submissions the average was 44 days from receipt to decision (median 44).
Which companies have the most GTI clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (2).
Next steps
- Run an FDA pathway report with predicate devices for product code GTI
- Run a recall and safety report across every GTI manufacturer
- Watch product code GTI 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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