510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QIPNot classified

Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents

Unknown
FDA source (opens on fda.gov)

QIP is the FDA product code for Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents. FDA's definition for this code reads: "Tests or reagents used to detect IgG and/or IgM antibodies to Ricketsia spp. (Spotted Fever Group or Typhus Group) in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Ricketsia spp. in patients suspected of exposure". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QIP
Device name
Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents
FDA definition
Tests or reagents used to detect IgG and/or IgM antibodies to Ricketsia spp. (Spotted Fever Group or Typhus Group) in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Ricketsia spp. in patients suspected of exposure.
Device class
Not classified
Review panel
Unknown
Submission type
Contact ODE
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QIP.