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Internal Polymerase Chain Reaction Control, Not Assay Specific

FDA product code OLD · 1 cleared devices

Class 1 Clinical Chemistry
Regulation
21 CFR 862.1660
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2009-01-15 – 2009-01-15

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.

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