← Product Code [IGN](/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/IGN) · K822129

# VOLU-SOL BOVINS FIXATIVE (K822129)

_Volu Sol Medical Industries · IGN · Aug 5, 1982 · Pathology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/IGN/K822129

## Device Facts

- **Applicant:** Volu Sol Medical Industries
- **Product Code:** [IGN](/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/IGN.md)
- **Decision Date:** Aug 5, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.4010
- **Device Class:** Class 1
- **Review Panel:** Pathology

## Regulatory Identification

A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test. General purpose reagents are appropriate for combining with one or more than one ASR in producing such systems and include labware or disposable constituents of tests; but they do not include laboratory machinery, automated or powered systems. General purpose reagents include cytological preservatives, decalcifying reagents, fixative and adhesives, tissue processing reagents, isotonic solutions and pH buffers. Reagents used in tests for more than one individual chemical substance or ligand are general purpose reagents (e.g., Thermus aquaticus (TAQ) polymerase, substrates for enzyme immunoassay (EIA)).

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**Source:** [https://fda.innolitics.com/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/IGN/K822129](https://fda.innolitics.com/submissions/PA/subpart-e%E2%80%94specimen-preparation-reagents/IGN/K822129)

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