CAT #: A3090070
BCL2/JH mcr - Unlabeled
This product targets the human BCL2/JH fusion gene.
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Analyte Specific Reagents (ASRs) may only be sold to:
- in vitro diagnostic manufacturers;
- clinical laboratories regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), as qualified to perform high complexity testing, or clinical laboratories regulated under VHA Directive 1106; and
- organizations that use the reagents to make tests for purposes other than providing diagnostic information to patients and practitioners, e.g., forensic, academic, research and other nonclinical laboratories. 21 CFR 809.30 (b).
Analyte Specific Reagent; Analytical and performance characteristics are not established.
Prior to ordering any ASR product, each customer facility must verify that they are a CLIA certified high-complexity laboratory.