Igg (Gamma Chain Specific), Antigen, Antiserum, Control
The IgG (Gamma Chain Specific) Antigen, Antiserum, and Control is an immunological reagent specifically targeting the gamma heavy chain of IgG immunoglobulins, used in laboratory assays to detect or measure IgG in clinical specimens. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 866.5510 within the Immunology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DFZ
- 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 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K092283 | DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG | Oct 21, 2009 | Substantially Equivalent | Siemens Healthcare Diagnostics |
| K021081 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER | Jun 17, 2002 | Substantially Equivalent | The Binding Site, Ltd. |
| K020823 | PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT | May 14, 2002 | Substantially Equivalent | Sanquin Blood Supply Foundation |
| K955906 | BOEHRINGER MANNHEIM IGG ASSAY | Feb 09, 1996 | Substantially Equivalent | Boehringer Mannheim Corp. |
| K940422 | IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER | May 27, 1994 | Substantially Equivalent | The Binding Site, Ltd. |
| K812821 | H-103 IGG, H-104 IGA, H-105 IGM | Oct 26, 1981 | Substantially Equivalent | Immulok, Inc. |
| K803272 | AUTOMATED IMMUNOPRECIPITIN METHOD/ICG | Jan 26, 1981 | Substantially Equivalent | Icl Scientific |
| K790720 | ANTISERA TO RABBIT IMMUNOGLOBULIN | Aug 16, 1979 | Substantially Equivalent | Kent Laboratories, Inc. |
| K790709 | ANTISERUM TO RABBIT IMMUNOGLOBULIN | Aug 16, 1979 | Substantially Equivalent | Kent Laboratories, Inc. |
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.