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Immunoassay, Pregnanediol Glucuronide, Over The Counter

FDA product code QKE · 1 cleared devices

Class 1 Clinical Chemistry
Regulation
21 CFR 862.1620
Review panel
TX
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2020-02-27 – 2020-02-27

Over-the-counter detection of pregnanediol glucuronide for the confirmation of ovulation

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