Identity
- Trade Name
- Acrometrix BB NAT HBV Positive Control FDA UDI
- Generic Name
- Hepatitis B virus antigen/antibody marker IVD, control FDA UDI
- Model / Reference
- 963603 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883006027 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Hepatitis B virus antigen/antibody marker 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
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: Hepatitis B virus antigen/antibody marker IVD, control
Acrometrix BB NAT HBV Positive Control by Microgenics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hepatitis B virus antigen/antibody marker IVD, control.
- ACCURUN® — LGC Clinical Diagnostics, Inc.
- ACCURUN® — LGC Clinical Diagnostics, Inc.
- ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mL — LGC Clinical Diagnostics, Inc. · Class I
- ACCURUN® — LGC Clinical Diagnostics, Inc.
- ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 6 x 3.5 mL — LGC Clinical Diagnostics, Inc. · Class I
- MAS anti-HBs Positive Control — Microgenics Corporation · Class I
- MAS anti-HBs Positive Control – For use with Siemens Assays — Microgenics Corporation · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Microgenics Corporation
Sources (1)
- FDA UDI 275b3cd3-d1f3-42cd-8c20-bc5d8d778234 32 fields · synced Jun 9, 2026