Identity
- Trade Name
- RealTime FDA UDI
- Generic Name
- Hepatitis B virus nucleic acid IVD, control FDA UDI
- Device Name
- Abbott RealTime HBV Control Kit FDA UDI
- Model / Reference
- 2N40-80 FDA UDI
- Description
- Abbott RealTime HBV Control Kit FDA UDI
Identifiers
- Catalog Number
- 2N40-80 FDA UDI
- Primary DI / UDI-DI
- 00884999003064 FDA UDI
- FDA Product Code
- MKT FDA UDI
- GMDN Term
- Hepatitis B virus nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3174 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: Hepatitis B virus nucleic acid IVD, control
RealTime by Abbott Molecular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hepatitis B virus nucleic acid IVD, control.
- Exact Diagnostics — Exact Diagnostics · Class I
- ACCURUN® — LGC Clinical Diagnostics, Inc. · Class I
- Aptima® — Hologic, Inc. · Class II
- Exact Diagnostics — Exact Diagnostics · Class I
- Procleix HIV-1/HCV/HBV Quality Control — Grifols Diagnostic Solutions Inc. · Class II
- Exact Diagnostics — Exact Diagnostics · Class I
- Alinity m — Abbott Molecular · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Molecular
Sources (1)
- FDA UDI 5f7e9812-26ea-4fd3-b9bc-ea4930786e0d 36 fields · synced May 30, 2026