# Immunology and Microbiology Devices; Revocation of the Exemption From Premarket Notification; Blood Culturing System Devices
> **Food and Drug Administration** · Final rule. · Published 1995-07-27 · Effective 1995-10-25 · 60 FR 38480
## Document
- **Document number:** 95-18446
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 60 FR 38480
- **CFR reference:** 21 CFR 866
- **Publication date:** 1995-07-27
- **Effective date:** 1995-10-25
- **HHS docket:** Docket No. 91N-0063
## Abstract

The Food and Drug Administration (FDA) is revising the microbial growth monitor classification regulation by revoking the exemption from the premarket notification requirements for automated blood culturing system devices used in testing blood and other normally sterile body fluids for bacteria, fungi, and other microorganisms. Revocation of the exemption is necessary because of the importance of these devices in providing rapid diagnosis of potentially life- threatening conditions. Devices using traditional manual methods employing turbidity measurements or direct counts, included under this classification regulation, will continue to be exempt from the requirement of premarket notification.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1995/07/27/95-18446/immunology-and-microbiology-devices-revocation-of-the-exemption-from-premarket-notification-blood)
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