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Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna

FDA product code QMI · 2 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3183
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2020-09-02 – 2025-03-24

An in vitro nucleic acid amplification test for the quantitation of BK virus (BKV) DNA in human samples intended for use as an aid in the management of BKV in transplant patients. In patients undergoing monitoring of BKV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment. Test results are intended to be read and analyzed by a qualified licensed healthcare professional in conjunction with clinical signs and symptoms and relevant laboratory findings. Test results must not be the sole basis for patient management decisions.

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