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

Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis

21 CFR 866.3370 / Microbiology
FDA source (opens on fda.gov)

NDZ is the FDA product code for Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis, a class I device type, regulated under 21 CFR 866.3370. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
NDZ
Device name
Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
Regulation
21 CFR 866.3370
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
1

Clearances, product code NDZ

By decision year
1 clearance under product code NDZ with a decision year between 2001 and 2001, 2001 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NDZ by decision year
YearClearances
20011

Applicants with the most clearances

Product code NDZ
Applicants holding the most 510(k) clearances under product code NDZ
ApplicantClearances
Becton Dickinson Biosciences1

Companies listing this code with FDA

Companies whose registered establishments list this code