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DImension Vista® sALB Flex® reagent cartridgeSpecialty Albumin
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- DImension Vista® sALB Flex® reagent cartridgeSpecialty Albumin FDA UDI
- Generic Name
- Albumin IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- For the quantitative measurement of albumin in human serum and plasma and cerebrospinal fluid (CSF) on the Dimension Vista® System FDA UDI
- Model / Reference
- 10445894 FDA UDI
- Description
- For the quantitative measurement of albumin in human serum and plasma and cerebrospinal fluid (CSF) on the Dimension Vista® System FDA UDI
Identifiers
- Catalog Number
- K7034 FDA UDI
- Primary DI / UDI-DI
- 00842768006098 FDA UDI
- FDA Product Code
- DCF FDA UDI
- GMDN Term
- Albumin IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5040 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
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: Albumin IVD, kit, nephelometry/turbidimetry
DImension Vista® sALB Flex® reagent cartridgeSpecialty Albumin by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Albumin IVD, kit, nephelometry/turbidimetry.
- Optilite Albumin Kit — The Binding Site Group · Class II
- Autokit Micro Albumin — FUJIFILM WAKO PURE CHEMICAL CORPORATION · Class I
- Atellica CH Alb — Siemens Healthcare Diagnostics · Class II
- ADVIA® Chemistry Albumin, ALB_c Albumin Reagents, Concentrated — Siemens Healthcare Diagnostics · Class II
- Yumizen C1200 Albumin U/CSF — Horiba Abx · Class II
- Atellica CH Urine Albumin (UAlb) — Siemens Healthcare Diagnostics · Class II
- Microalbuminuria Kit (Immunoturbidimetric Method) — Medicalsystem Biotechnology Co., Ltd. · Class II
- ADVIA® Chemistry ALB Albumin BCG Reagents — Siemens Healthcare Diagnostics · 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 |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI c2b41eae-d663-4745-93d1-4d9f62e20f6f 36 fields · synced Jun 1, 2026