Identity
- Trade Name
- Dimension® EXL™ VB12 Flex® reagent cartridge FDA UDI
- Generic Name
- Vitamin B12 IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- LOCI Vitamin B12 Flex® reagent cartridge, 80 tests FDA UDI
- Model / Reference
- 10463371 FDA UDI
- Description
- LOCI Vitamin B12 Flex® reagent cartridge, 80 tests FDA UDI
Identifiers
- Catalog Number
- RF642 FDA UDI
- Primary DI / UDI-DI
- 00630414976624 FDA UDI
- 510(k) Number
- K133512 FDA UDI
- FDA Product Code
- CDD FDA UDI
- GMDN Term
- Vitamin B12 IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1810 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
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: Vitamin B12 IVD, kit, chemiluminescent immunoassay
Dimension® EXL™ VB12 Flex® reagent cartridge by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vitamin B12 IVD, kit, chemiluminescent immunoassay.
- LIAISON® Vitamin B12 — Diasorin Inc. · Class II
- ARCHITECT — ABBOTT IRELAND · Class II
- IMMULITE® 2000 Systems VB Vitamin B12 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Access Vitamin B12 — Beckman Coulter, Inc. · Class II
- ARCHITECT — ABBOTT IRELAND · Class II
- IMMULITE®/IMMULITE® 1000 Systems VB Vitamin B12 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Elecsys Vitamin B12 II — Roche Diagnostics Corp. · Class II
Cleared under the same submission
K133512 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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 038c57d3-ed8c-4b2c-a761-33236e8d3e0d 37 fields · synced Jun 8, 2026