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IMMULITE® 2000 Systems aBC Calibration Verification Material Anti-HBC
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- IMMULITE® 2000 Systems aBC Calibration Verification Material Anti-HBC FDA UDI
- Generic Name
- Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control FDA UDI
- Device Name
- Anti-HBc IgM CVM - IMMULITE - CONS FDA UDI
- Model / Reference
- 10373676 FDA UDI
- Description
- Anti-HBc IgM CVM - IMMULITE - CONS FDA UDI
Identifiers
- Catalog Number
- L2MCCVM FDA UDI
- Primary DI / UDI-DI
- 00630414978017 FDA UDI
- PMA Number
- P030040 FDA UDI
- FDA Product Code
- LOM FDA UDI
- GMDN Term
- Hepatitis B virus core immunoglobulin M (IgM) antibody 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
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
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 core immunoglobulin M (IgM) antibody IVD, control
IMMULITE® 2000 Systems aBC Calibration Verification Material Anti-HBC by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control.
- VIROTROL — Bio-Rad Laboratories · Class I
- Atellica™ IM aHBcM QC — Siemens Healthcare Diagnostics · Class II
- ARCHITECT — Abbott · Class II
- MONOLISA™ — Bio-Rad Laboratories · Class II
- Alinity — Abbott · Class II
- PreciControl Anti-HBc IgM — Roche Diagnostics Corp. · Class II
- ADVIA Centaur® Systems HBc IgM QC — Siemens Healthcare Diagnostics · Class II
- LIAISON XL MUREX Control HBcIgM — Diasorin Inc.
Cleared under the same submission
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
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 95efffc1-5e56-4b8c-9d65-f962c4520d7d 37 fields · synced May 30, 2026