Whole Human Serum, Antigen, Antiserum, Control
The Whole Human Serum Antigen, Antiserum, and Control is an immunological reagent derived from human serum, used as a reference standard or control material for detecting and characterizing serum proteins in laboratory assays. It is classified as FDA Class 1, the lowest risk designation, subject only to general controls and exempt from premarket notification requirements. The device is regulated under 21 CFR 866.5700 within the Immunology specialty.
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Basic Information
- Product Code
- DGR
- Device Class
- FDA class 1
- Regulation Number
- 866.5700
- Medical Specialty
- Immunology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K961544 | QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 | Sep 24, 1996 | Substantially Equivalent | Consolidated Technologies, Inc. |
| K902220 | PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL | Sep 05, 1990 | Substantially Equivalent | Boehringer Mannheim Corp. |
| K865014 | LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II | Jan 09, 1987 | Substantially Equivalent | Bio-Rad |
| K790298 | RADIOASSAY, CONTROL SERUM I, II, III | Apr 04, 1979 | Substantially Equivalent | Kallestad Laboratories, Inc. |
| K781355 | ICS NORMAL CONTROL SERUM | Aug 31, 1978 | Substantially Equivalent | Beckman Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.