Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1810](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1810) → LIG — Radioassay, Intrinsic Factor Blocking Antibody

# LIG · Radioassay, Intrinsic Factor Blocking Antibody

_Clinical Chemistry · 21 CFR 862.1810 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LIG

## Overview

- **Product Code:** LIG
- **Device Name:** Radioassay, Intrinsic Factor Blocking Antibody
- **Regulation:** [21 CFR 862.1810](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1810)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **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.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K240800](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LIG/K240800.md) | Access Intrinsic Factor Ab | Beckman Coulter, Inc. | May 3, 2024 | SESE |
| [K071346](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LIG/K071346.md) | IMMULISA INTRINSIC FACTOR ANTIBODY ELISA | Immco Diagnostics, Inc. | Sep 24, 2007 | SESE |
| [K061841](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LIG/K061841.md) | QUANTA LITE INTRINSIC FACTOR ELISA | Inova Diagnostics, Inc. | Dec 22, 2006 | SESE |
| [K033603](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LIG/K033603.md) | INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 | Beckman Coulter, Inc. | Dec 19, 2003 | SESE |
| [K993251](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LIG/K993251.md) | IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 | Diagnostic Products Corp. | Nov 17, 1999 | SESE |
| [K984108](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LIG/K984108.md) | ABBOTT ARCHITECT B12 | Abbott Laboratories | Feb 3, 1999 | SESE |
| [K903218](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LIG/K903218.md) | IMX B12 | Abbott Laboratories | Aug 23, 1990 | SESE |
| [K811927](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LIG/K811927.md) | 1F BLOCKING ANTIBODY(57 CO) RADIOASSAY | Corning Medical & Scientific | Apr 1, 1982 | SESE |

## Top Applicants

- Abbott Laboratories — 2 clearances
- Beckman Coulter, Inc. — 2 clearances
- Corning Medical & Scientific — 1 clearance
- Diagnostic Products Corp. — 1 clearance
- Immco Diagnostics, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LIG](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LIG)

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