Class II Special Controls Guideline

U.S. Food and Drug Administration. (2014). Class II Special Controls Guideline: Automated Blood Culture System Devices for Testing of Bloodborne Microorganisms.

Type

Report

Intellectual base

Grey literature

Year

2014

Link

https://www.fda.gov/media/92177/download

Cited by

1 citation across 1 artifact.

Domain-specific

• Blood Culture
  • Growth detector. Visual/manual observation or an automated continuous-monitoring system that detects metabolic evidence of growth and records a time-to-positivity signal.

Verification

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Registry ID ref:a33bcedb9786 · see in the full table