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

Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis

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

NRL is the FDA product code for Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis, a class II device type, regulated under 21 CFR 866.3045. FDA's definition for this code reads: "The elisa assay for antibodies to b. Anthracis is used to detect an immunological response to proteins secreted by b. Anthracis; As an aid in the laboratory diagnosis of anthrax". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NRL
Device name
Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis
FDA definition
The elisa assay for antibodies to b. Anthracis is used to detect an immunological response to proteins secreted by b. Anthracis; As an aid in the laboratory diagnosis of anthrax.
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 NRL

By decision year
1 clearance under product code NRL with a decision year between 2004 and 2004, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NRL by decision year
YearClearances
20041

Applicants with the most clearances

Product code NRL
Applicants holding the most 510(k) clearances under product code NRL
ApplicantClearances
Immunetics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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