Identity
- Trade Name
- PreciControl HBeAg FDA UDI
- Generic Name
- Hepatitis B virus e-antigen IVD, control FDA UDI
- Model / Reference
- 11876376160 FDA UDI
Identifiers
- Catalog Number
- 11876376160 FDA UDI
- Primary DI / UDI-DI
- 07613336154298 FDA UDI
- PMA Number
- P130015 FDA UDI
- FDA Product Code
- LOM FDA UDI
- GMDN Term
- Hepatitis B virus e-antigen IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3172 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
No
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: Hepatitis B virus e-antigen IVD, control
PreciControl HBeAg by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hepatitis B virus e-antigen IVD, control.
Cleared under the same submission
P130015 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 78ecb779-4a14-40db-9d3b-579f2460eee2 35 fields · synced Jun 8, 2026