Gamma Globulin, Antigen, Antiserum, Control
This is an immunological reagent kit for detecting gamma globulin, the serum protein fraction encompassing the majority of circulating antibodies, including antigen, antiserum, and control components for laboratory immunoassays. Gamma globulin measurements are used to assess immune function and diagnose hypergammaglobulinemia and related disorders. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DAH, regulated under 21 CFR 866.5510, within the Immunology specialty.
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Basic Information
- Product Code
- DAH
- Device Class
- FDA class 2
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K931247 | TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 | Apr 27, 1993 | Substantially Equivalent | Helena Laboratories |
| K905149 | TITAN GEL | Jan 03, 1991 | Substantially Equivalent | Helena Laboratories |
| K901805 | REP(R) IMMUNOFIX | Jun 06, 1990 | Substantially Equivalent | Helena Laboratories |
| K884074 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G | Oct 27, 1988 | Substantially Equivalent | Orion Diagnostica, Inc. |
| K883494 | TECHNICON DPA-1 IMMUNOGLOBULIN G | Sep 07, 1988 | Substantially Equivalent | Technicon Instruments Corp. |
| K854944 | TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT | Aug 27, 1986 | Substantially Equivalent | Abbott Laboratories |
| K862184 | DAKO ITA, IMMUNOGLOBULIN M (IGM) | Aug 19, 1986 | Substantially Equivalent | Dako Corp. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.