Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

OPM · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3510

Classification

FDA Product Code: OPM
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3510
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown