Titan Gel IFE Antiserum to IGD-9409 & IGE-9410
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K872834 FDA 510(k)
- FDA Product Code
- CZJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5510 FDA 510(k)
- Regulation Number
- 866.5510 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Titan Gel IFE Antiserum to IgD-9409 & IgE-9410 is an immunology device classified as an antigen, antiserum, and control. It is designed for use in immunoglobulin detection and identification procedures.
The device is supplied as a reagent in specified volumes and is intended for laboratory use. It received FDA 510(k) clearance under K872834 on August 12, 1987, and is regulated under product code CZJ and regulation number 866.5510.
Frequently asked questions
What is the Titan Gel IFE Antiserum to IgD-9409 & IgE-9410 used for?
It is designed for use in immunoglobulin detection and identification procedures as an antigen, antiserum, and control in immunology testing.
How is the Titan Gel IFE Antiserum supplied and intended for use?
The device is supplied as a reagent in specified volumes and is intended for laboratory use in immunology applications.
What regulatory pathway was used for the Titan Gel IFE Antiserum to IgD-9409 & IgE-9410?
It received FDA 510(k) clearance under K872834 on August 12, 1987, and is regulated under product code CZJ and regulation number 866.5510.
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: TITAN Gel Proteins | Helena Laboratories - Innovations for Science ..., PDF TITAN GEL ImmunoFix - helena.com, Titan Gel Ife Antiserum to Igd-9409 & Ige-9410, TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K872834 | Class II | Active |
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Manufacturer
- Manufacturer
- Helena Laboratories
Sources (1)
- FDA 510(k) K872834 24 fields · synced Oct 6, 2026