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PUQClass II

Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm

21 CFR 866.3510 / Microbiology
FDA source (opens on fda.gov)

PUQ is the FDA product code for Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm, a class II device type, regulated under 21 CFR 866.3510. FDA's definition for this code reads: "The kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PUQ
Device name
Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm
FDA definition
The kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma.
Regulation
21 CFR 866.3510
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 PUQ

By decision year
1 clearance under product code PUQ with a decision year between 2017 and 2017, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PUQ by decision year
YearClearances
20171

Applicants with the most clearances

Product code PUQ
Applicants holding the most 510(k) clearances under product code PUQ
ApplicantClearances
Bio-Rad Laboratories Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code