Identity
- Trade Name
- Dimension® Flex® reagent cartridge ALB FDA UDI
- Generic Name
- Albumin IVD, kit, spectrophotometry FDA UDI
- Device Name
- Albumin Flex® reagent cartridge, 480 tests FDA UDI
- Model / Reference
- 10444975 FDA UDI
- Description
- Albumin Flex® reagent cartridge, 480 tests FDA UDI
Identifiers
- Catalog Number
- DF13 FDA UDI
- Primary DI / UDI-DI
- 00842768005343 FDA UDI
- 510(k) Number
- K861700 FDA UDI
- FDA Product Code
- CJW FDA UDI
- GMDN Term
- Albumin IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1035 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: Albumin IVD, kit, spectrophotometry
Dimension® Flex® reagent cartridge ALB by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Albumin IVD, kit, spectrophotometry.
- Pointe Albumin on BS480 Analyzer — POINTE SCIENTIFIC, INC. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Diazyme — Diazyme Laboratories, Inc.
- Albumin Gen.2 — Roche Diagnostics Corp. · Class II
- ENVOY 500 ALBUMIN REAGENT KIT — VITALSCIENTIFIC
- Pointe Scientific, Inc. Albumin — POINTE SCIENTIFIC, INC. · Class II
- ARCHITECT — ABBOTT IRELAND · Class II
- Synchron — Beckman Coulter, Inc. · Class II
Cleared under the same submission
K861700 also covers:
- Dimension® CHEM II Calibrator — Siemens Healthcare Diagnostics
- Dimension® CHOL Calibrator — Siemens Healthcare Diagnostics
- Dimension® Flex® reagent cartridge CHOL — Siemens Healthcare Diagnostics
- Dimension® Flex® reagent cartridge GGT — Siemens Healthcare Diagnostics
- Dimension® Flex® reagent cartridge MG — Siemens Healthcare Diagnostics
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 2f511ec1-ce74-45c9-a2c2-f2bba8ce030b 37 fields · synced May 30, 2026