510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MKTClass II

Hepatitis Viral B Dna Detection

21 CFR 866.3174 / Microbiology
FDA source (opens on fda.gov)

MKT is the FDA product code for Hepatitis Viral B Dna Detection, a class II device type, regulated under 21 CFR 866.3174. FDA's definition for this code reads: "Nucleic acid assay for detection of Hepatitis B Virus (HBV) DNA is an in vitro nucleic acid assay for detection and quantitation of HBV DNA in human serum or plasma. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The test results must be...". As of , FDA records hold no 510(k) clearances under this code and 7 recalls.

Classification record

Product code
MKT
Device name
Hepatitis Viral B Dna Detection
FDA definition
Nucleic acid assay for detection of Hepatitis B Virus (HBV) DNA is an in vitro nucleic acid assay for detection and quantitation of HBV DNA in human serum or plasma. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.
Regulation
21 CFR 866.3174
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
7

Companies listing this code with FDA

Companies whose registered establishments list this code