Identity
- Trade Name
- Atellica CH Urine Albumin (UAlb) FDA UDI
- Generic Name
- Albumin IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Atellica CH Microalbumin (UAlb) Reagent FDA UDI
- Model / Reference
- 11537225 FDA UDI
- Description
- Atellica CH Microalbumin (UAlb) Reagent FDA UDI
Identifiers
- Catalog Number
- 11537225 FDA UDI
- Primary DI / UDI-DI
- 00630414611099 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
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
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
Atellica CH Urine Albumin (UAlb) by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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
- N Antiserum to Human Albumin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Yumizen C1200 Albumin U/CSF — Horiba Abx · Class II
- Microalbuminuria Kit (Immunoturbidimetric Method) — Medicalsystem Biotechnology Co., Ltd. · Class II
- ABX PENTRA MICRO ALBUMIN CP — Horiba Abx · Class II
- DImension Vista® Microalbumin Flex® reagent cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Tinaquant Albumin — Roche Diagnostics Corp. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (2)
- FDA UDI 03b94cc5-02fe-4d4f-bc4a-6d7fdd52cadd 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026