OPM · Class II · 21 CFR 866.3510

FDA Product Code OPM: Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

The Test Is A Multiplex Immunoassay Intended For The Qualitative Detection Of Specific Human Igg Antibodies To Toxoplasma Gondii (t.gondii), Rubella, Cytomegalovirus (cmv) And Herpes Simplex Virus 1 & 2 (hsv 1 And Hsv 2) In Human Serum. The Results Of This Assay Are Intended To Be Used As An Aid In The Assessment Of A Patient's Serological Status To Toxoplasma Gondii, Rubella, Cmv And Hsv 1 & 2. The Test Is Not Intended For Use In Screening Blood Or Plasma Donors.

1
Total
1
Cleared
219d
Avg days
2010
Since

FDA 510(k) Cleared Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2 Devices (Product Code OPM)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code OPM - Regulatory Context