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

Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast

21 CFR 866.2660 / Microbiology
FDA source (opens on fda.gov)

NZS is the FDA product code for Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast, a class I device type, regulated under 21 CFR 866.2660. FDA's definition for this code reads: "Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NZS
Device name
Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
FDA definition
Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast.
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code NZS

By decision year
3 clearances under product code NZS with a decision year between 2010 and 2010, 2010 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code NZS by decision year
YearClearances
20103

Applicants with the most clearances

Product code NZS
Applicants holding the most 510(k) clearances under product code NZS
ApplicantClearances
Advandx, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NZS.