Identity
- Trade Name
- Exact Diagnostics FDA UDI
- Generic Name
- Bartonella quintana nucleic acid IVD, control FDA UDI
- Device Name
- Bartonella Run Control FDA UDI
- Model / Reference
- BRTRC FDA UDI
- Description
- Bartonella Run Control FDA UDI
Identifiers
- Catalog Number
- BRTRC FDA UDI
- Primary DI / UDI-DI
- 00812242030789 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- Bartonella quintana nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Bartonella quintana nucleic acid IVD, control
Exact Diagnostics by Exact Diagnostics — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Exact Diagnostics
Sources (1)
- FDA UDI 81d6f027-63e6-4a5b-ad22-885ba65f8fc9 36 fields · synced Jun 9, 2026