Babesia Spp. Serological Reagents

QIN · Not classified · Unknown

Classification

FDA Product Code: QIN
Device class: Not classified
Regulation: —
Review panel: MI
Medical specialty: Unknown
Submission type: 3
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Tests or reagents used to detect IgG and/or IgM antibodies to Babesia spp. in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Babesia spp. in patients suspected of exposure.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 2

Source

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