← Product Code [MLM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM) · P970007

# IMX TACROLIMUS II ASSAY (P970007)

_Abbott Laboratories · MLM · Aug 26, 1997 · Clinical Chemistry · APRL_

**Canonical URL:** https://fda.innolitics.com/submissions/CLINICAL%20TOXICOLOGY/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM/P970007

## Device Facts

- **Applicant:** Abbott Laboratories
- **Product Code:** [MLM](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM.md)
- **Decision Date:** Aug 26, 1997
- **Decision:** APRL
- **Regulation:** 21 CFR 862.1678
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry
- **Attributes:** Expedited Review

## Regulatory Identification

A tacrolimus test system is a device intended to quantitatively determine tacrolimus concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for tacrolimus.

## Special Controls

*Classification.* Class II (special controls). The special control is “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA.” See § 862.1(d) for the availability of this guidance document.

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**Source:** [https://fda.innolitics.com/submissions/CLINICAL%20TOXICOLOGY/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM/P970007](https://fda.innolitics.com/submissions/CLINICAL%20TOXICOLOGY/subpart-b%E2%80%94clinical-chemistry-test-systems/MLM/P970007)

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