Identifiers
- 510(k) Number
- K883685 FDA 510(k)
- FDA Product Code
- GNC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3550 FDA 510(k)
- Regulation Number
- 866.3550 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Immunofebrile Antigens are in vitro diagnostic devices used for microbiology testing. These antigens are designed for slide and tube tests to detect antibodies against Salmonella spp. in all groups.
The device is supplied as a class 2 product with FDA 510(k) clearance K883685, received on 1988-08-29 and cleared on 1988-09-28. It is regulated under product code GNC and regulation number 866.3550, manufactured by Immunostics Co., Inc. for use in microbiology laboratories.
Frequently asked questions
What are Immunofebrile Antigens used for?
Immunofebrile Antigens are in vitro diagnostic devices used for microbiology testing to detect antibodies against Salmonella spp. in all groups through slide and tube tests.
How are Immunofebrile Antigens supplied?
The device is supplied as a class 2 product manufactured by Immunostics Co., Inc. for use in microbiology laboratories, with FDA 510(k) clearance K883685.
What regulatory status do Immunofebrile Antigens have?
Immunofebrile Antigens have FDA 510(k) clearance K883685, received on 1988-08-29 and cleared on 1988-09-28, regulated under product code GNC and regulation number 866.3550.
Are there different sizes or models of Immunofebrile Antigens available?
The device is designed for slide and tube tests to detect antibodies against Salmonella spp. in all groups, with multiple registration numbers indicating different manufacturing lots or batches.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: IMMUNO/FEBRILE ANTIGENS (K883685) — FDA 510(k) | Innolitics, 510 (k) K883685 — IMMUNO/FEBRILE ANTIGENS — RegDataLab, IMMUNO/FEBRILE ANTIGENS 510 (k) K883685 - FDA.report, api.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K883685 | Class II | Active |
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Manufacturer
- Manufacturer
- Immunostics Co., Inc.
Sources (1)
- FDA 510(k) K883685 24 fields · synced Sep 25, 2026