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

System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

21 CFR 866.1640 / Microbiology
FDA source (opens on fda.gov)

NIJ is the FDA product code for System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species, a class II device type, regulated under 21 CFR 866.1640. FDA's definition for this code reads: "The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp. as a marker for vancomycin resistance using DNA probe technology". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NIJ
Device name
System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
FDA definition
The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp. as a marker for vancomycin resistance using DNA probe technology
Regulation
21 CFR 866.1640
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
6
Ingested recalls
0

Clearances, product code NIJ

By decision year
6 clearances under product code NIJ with a decision year between 2002 and 2024, 2002 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NIJ by decision year
YearClearances
20021
20061
20091
20111
20131
20241

Applicants with the most clearances

Product code NIJ
Applicants holding the most 510(k) clearances under product code NIJ
ApplicantClearances
Cepheid2
BD Diagnostics Science1
Geneohm Sciences Canada, Inc.1
Id Biomedical Corp.1
Intelligent Medical Devices, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code