FDA product code GWD: Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp
GWD is the FDA product code for indirect fluorescent antibody test, entamoeba histolytica & rel sp. It is a Class II device, regulated under 21 CFR 866.3220 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under GWD, from 2 different applicants. The average 510(k) review took 36 days (median 36). FDA has posted 3 recalls for GWD devices.
Classification
| Field | Value |
|---|---|
| Device name | Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp |
| Device class | Class II |
| Regulation | 21 CFR 866.3220 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GWD clearance
Top GWD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Diagnostics, Inc. | 1 | 1987-09-16 |
| Edward Weck, Inc. | 1 | 1985-01-23 |
Most recent GWD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K873299 | Meridian Diagnostics, Inc. | MERIFLUOR(TM)-GIARDIA | 1987-09-16 | 29 |
| K844836 | Edward Weck, Inc. | HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER | 1985-01-23 | 42 |
Recalls for GWD devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-07-16.
Frequently asked questions
What is FDA product code GWD?
GWD is the FDA product code for indirect fluorescent antibody test, entamoeba histolytica & rel sp. It is a Class II device, regulated under 21 CFR 866.3220 and reviewed by the Microbiology panel.
What device class is GWD?
Class II, regulation 21 CFR 866.3220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GWD?
Across 2 cleared submissions the average was 36 days from receipt to decision (median 36).
Which companies have the most GWD clearances?
Meridian Diagnostics, Inc. (1); Edward Weck, Inc. (1).
Have GWD devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2007-07-16.
Next steps
- Run an FDA pathway report with predicate devices for product code GWD
- Run a recall and safety report across every GWD manufacturer
- Watch product code GWD 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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