FDA product code GSY: Antisera, Fluorescent, All Globulins, Proteus Spp.
GSY is the FDA product code for antisera, fluorescent, all globulins, proteus spp.. It is a Class I device, regulated under 21 CFR 866.3410 and reviewed by the Microbiology panel. Devices under GSY reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for GSY devices.
Classification
| Field | Value |
|---|---|
| Device name | Antisera, Fluorescent, All Globulins, Proteus Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3410 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for GSY devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-10-20.
Frequently asked questions
What is FDA product code GSY?
GSY is the FDA product code for antisera, fluorescent, all globulins, proteus spp.. It is a Class I device, regulated under 21 CFR 866.3410 and reviewed by the Microbiology panel.
What device class is GSY?
Class I, regulation 21 CFR 866.3410. Typical premarket route: 510(k) exempt.
Have GSY devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2004-10-20.
Next steps
- Run an FDA pathway report with predicate devices for product code GSY
- Run a recall and safety report across every GSY manufacturer
- Watch product code GSY 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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