PUQ · Class II · 21 CFR 866.3510

FDA Product Code PUQ: Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm

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.

Leading manufacturers include Bio-Rad Laboratories.

Total

Cleared

87d

Avg days

2017

Since

FDA 510(k) Cleared Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm Devices (Product Code PUQ)

1 devices

1–1 of 1

Cleared May 19, 2017

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set

K170509

Bio-Rad Laboratories

Microbiology · 87d

About Product Code PUQ - Regulatory Context

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Data Source

FDA 510(k) public files . 175,450 total devices indexed.

Latest clearance: May 19, 2017

Product Code Info

Code	PUQ
Device class	Class II
CFR	21 CFR 866.3510
Panel	Microbiology

Verify on FDA.gov

View PUQ classification on FDA.gov →