№ files_lp_4_process_3_061708
File format: docx Character count: 16938 File size: 130 KB
Guidance document for clinical and physician office laboratories detailing assessment criteria, historical background, and performance evaluation requirements for professional-use hCG in vitro diagnostic devices.
Year: 1997
Region / City: United States, Rockville, Maryland
Topic: Human Chorionic Gonadotropin (hCG) Diagnostic Testing
Document Type: Guidance / Regulatory Document
Organization / Institution: U.S. Food and Drug Administration (FDA)
Author: Cornelia Rooks, Chief, Clinical Chemistry, Toxicology, and Hematology Branch
Target Audience: Clinical laboratories, physician office laboratories
Regulatory Reference: 21 CFR §862.1155
Classification: Class II (performance standards)
Product Codes: JHJ, DHA, JHI
Purpose: Provide criteria and guidance for FDA submission of professional-use hCG IVDs
Date Issued: February 27, 1997
Scientific Basis: Basic science, clinical experience, manufacturer submissions, Safe Medical Devices Act of 1990
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Pregnancy Test Using CLINITEST hCG on the CLINITEK Status analyser
Note: Year
Topic: Medical Diagnostics
Document Type: Standard Operating Procedure (SOP)
Organization: Siemens
Author: Jane Mason
Target Audience: Medical professionals
Period of Use: Indefinite
Topics: Chorionic Gonadotropin hCG