510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NPOClass II

Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody

21 CFR 866.3045 / Microbiology
FDA source (opens on fda.gov)

NPO is the FDA product code for Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody, a class II device type, regulated under 21 CFR 866.3045. FDA's definition for this code reads: "A serological reagent to distinguish b. Anthracis culture growth from other bacillus spp. Growth". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NPO
Device name
Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody
FDA definition
A serological reagent to distinguish b. Anthracis culture growth from other bacillus spp. Growth
Regulation
21 CFR 866.3045
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
1
Ingested recalls
0

Clearances, product code NPO

By decision year
1 clearance under product code NPO with a decision year between 2003 and 2003, 2003 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NPO by decision year
YearClearances
20031

Applicants with the most clearances

Product code NPO
Applicants holding the most 510(k) clearances under product code NPO
ApplicantClearances
Tetracore, Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code