QIMNot classified

Bartonella Spp. Serological Reagents

Unknown

QIM is the FDA product code for Bartonella Spp. Serological Reagents. FDA's definition for this code reads: "Tests or reagents used to detect IgG and/or IgM antibodies to Bartonella spp. in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Bartonella spp. in patients suspected of exposure". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: QIM
Device name: Bartonella Spp. Serological Reagents
FDA definition: Tests or reagents used to detect IgG and/or IgM antibodies to Bartonella spp. in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Bartonella 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

VMRD, Inc.

Recent clearances

Product code QIM

FDA records hold no clearances under product code QIM.

Recent recalls

Product code QIM

FDA records show no recalls under product code QIM.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)