№ lp_1_2_08710
File format: docx Character count: 10629 File size: 385 KB
This document provides detailed instructions for conducting a pregnancy test using the CLINITEST hCG on the CLINITEK Status analyser, outlining sample preparation, test procedures, and safety measures.
Note: Year
Topic: Medical Diagnostics
Document Type: Standard Operating Procedure (SOP)
Organization: Siemens
Author: Jane Mason
Target Audience: Medical professionals
Period of Use: Indefinite
Price: 8 / 10 USD
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Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs)
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
Topics: CLINITEST CLINITEK hCG