Identity
- Trade Name
- IMMUNODOT™ COXIELLA BURNETII (Q FEVER) FDA UDI
- Generic Name
- Coxiella burnetii total antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ImmunoDOT test is an enzyme immunoassay for the qualitative detection of antibodies to Coxiella burnetii in serum specimens and is used as an aid in the diagnosis of C. burnetii (Q fever) infection. The test is used as an aid for diagnosis of C. burnetii (Q fever) infection in subjects suspected with consistent signs and symptoms to suspect the infection. FDA UDI
- Model / Reference
- 800-4050 FDA UDI
- Description
- The ImmunoDOT test is an enzyme immunoassay for the qualitative detection of antibodies to Coxiella burnetii in serum specimens and is used as an aid in the diagnosis of C. burnetii (Q fever) infection. The test is used as an aid for diagnosis of C. burnetii (Q fever) infection in subjects suspected with consistent signs and symptoms to suspect the infection. FDA UDI
Identifiers
- Catalog Number
- 4050 FDA UDI
- Primary DI / UDI-DI
- 00613745000039 FDA UDI
- FDA Product Code
- GPJ FDA UDI
- GMDN Term
- Coxiella burnetii total 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coxiella burnetii total antibody IVD, kit, enzyme immunoassay (EIA)
Immunodot™ Coxiella Burnetii (q Fever) by Genbio — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Genbio
Sources (1)
- FDA UDI 13202341-d05d-4b8e-8f16-d91fc5606e4b 37 fields · synced May 29, 2026