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

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

21 CFR 866.3170 / Microbiology
FDA source (opens on fda.gov)

MZP is the FDA product code for Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus, a class II device type, regulated under 21 CFR 866.3170. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
MZP
Device name
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Regulation
21 CFR 866.3170
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
4
Ingested recalls
11

Clearances, product code MZP

By decision year
4 clearances under product code MZP with a decision year between 2022 and 2025, 2025 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MZP by decision year
YearClearances
20221
20241
20252

Applicants with the most clearances

Product code MZP
Applicants holding the most 510(k) clearances under product code MZP
ApplicantClearances
Roche Molecular Systems Inc2
Abbott Molecular, Inc.1
Hologic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code