Identity
- Trade Name
- C. burnetii 12 Well 10 pk FDA UDI
- Generic Name
- Coxiella burnetii total antibody IVD, kit, fluorescent immunoassay FDA UDI
- Model / Reference
- I-QFB01X FDA UDI
Identifiers
- Catalog Number
- I-QFB01X FDA UDI
- Primary DI / UDI-DI
- 00813545026073 FDA UDI
- FDA Product Code
- LSQ FDA UDI
- GMDN Term
- Coxiella burnetii total antibody IVD, kit, fluorescent immunoassay 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
No
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
No
FDA UDI
Category: Coxiella burnetii total antibody IVD, kit, fluorescent immunoassay
C. burnetii 12 Well 10 pk by Scimedx Corp. — 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
- Scimedx Corp.
Sources (1)
- FDA UDI b4e175c7-786b-4e2f-bfc2-097d6501c69c 34 fields · synced Jun 8, 2026