← Product Code [CIG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG) · K812841

# TOTAL & DIRECT BILIRUBIN REAGENT SET (K812841)

_Anco Medical Reagents & Assoc. · CIG · Nov 27, 1981 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG/K812841

## Device Facts

- **Applicant:** Anco Medical Reagents & Assoc.
- **Product Code:** [CIG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG.md)
- **Decision Date:** Nov 27, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1110
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG/K812841](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG/K812841)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com