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Internal Polymerase Chain Reaction Control, Not Assay Specific

Internal Polymerase Chain Reaction Control, Not Assay Specific is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
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Internal Polymerase Chain Reaction Control, Not Assay Specific
Clinical Chemistry Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OLD

View Product Code Classification

Class 1

21 CFR 862.1660

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Clinical Chemistry

Device Characteristics

No

No

No

Not Eligible

Definition

Internal control that can be used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.