LIG · Radioassay, Intrinsic Factor Blocking Antibody
Clinical Chemistry · 21 CFR 862.1810 · Class 2
Overview
| Product Code | LIG |
|---|---|
| Device Name | Radioassay, Intrinsic Factor Blocking Antibody |
| Regulation | 21 CFR 862.1810 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
Classification Rationale
Class II.
Cleared Devices (8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240800 | Access Intrinsic Factor Ab | Beckman Coulter, Inc. | May 3, 2024 | SESE |
| K071346 | IMMULISA INTRINSIC FACTOR ANTIBODY ELISA | Immco Diagnostics, Inc. | Sep 24, 2007 | SESE |
| K061841 | QUANTA LITE INTRINSIC FACTOR ELISA | Inova Diagnostics, Inc. | Dec 22, 2006 | SESE |
| K033603 | INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 | Beckman Coulter, Inc. | Dec 19, 2003 | SESE |
| K993251 | IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 | Diagnostic Products Corp. | Nov 17, 1999 | SESE |
| K984108 | ABBOTT ARCHITECT B12 | Abbott Laboratories | Feb 3, 1999 | SESE |
| K903218 | IMX B12 | Abbott Laboratories | Aug 23, 1990 | SESE |
| K811927 | 1F BLOCKING ANTIBODY(57 CO) RADIOASSAY | Corning Medical & Scientific | Apr 1, 1982 | SESE |
Top Applicants
- Beckman Coulter, Inc. — 2 clearances
- Abbott Laboratories — 2 clearances
- Inova Diagnostics, Inc. — 1 clearance
- Immco Diagnostics, Inc. — 1 clearance
- Diagnostic Products Corp. — 1 clearance
