FDA product code QIO

Anaplasma Spp. And Ehrlichia Spp. Serological Reagents

Unknown·Class N·21 CFR
US regulatory classifications
US Product Code (FDA)
QIO
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US Risk Class (FDA)
Class N
US Regulation (CFR)
21 CFR
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Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

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

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About this record

Anaplasma Spp. And Ehrlichia Spp. Serological Reagents is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.