Identity
- Trade Name
- CHORUS Q FEVER PHASE II IgG FDA UDI
- Generic Name
- Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 81171 FDA UDI
Identifiers
- Catalog Number
- 81171 FDA UDI
- Primary DI / UDI-DI
- 08033891322083 FDA UDI
- FDA Product Code
- GPS FDA UDI
- GMDN Term
- Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
CHORUS Q FEVER PHASE II IgG by Diesse Diagnostica Senese Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
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- Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- NovaLisa Coxiella burnetii (Q-Fever) Phase 1 IgG — Gold Standard Diagnostics Frankfurt GmbH · Class I
- Coxiella burnetii (Q-Fever) Phase 1 IgG ELISA — DRG International, Inc. · Class I
- NovaLisa Coxiella burnetii (Q-Fever) Phase 2 IgG — Gold Standard Diagnostics Frankfurt GmbH · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Diesse Diagnostica Senese Spa
Sources (1)
- FDA UDI 078dc65e-aac7-45e2-a3c8-69133e2f99d8 34 fields · synced May 31, 2026