Identity
- Trade Name
- Atellica CH Alb FDA UDI
- Generic Name
- Albumin IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Albumin BCG (Alb) Atellica CH - RGT 6800T FDA UDI
- Model / Reference
- 11097590 FDA UDI
- Description
- Albumin BCG (Alb) Atellica CH - RGT 6800T FDA UDI
Identifiers
- Catalog Number
- 11097590 FDA UDI
- Primary DI / UDI-DI
- 00630414596501 FDA UDI
- 510(k) Number
- K991576 FDA UDI
- FDA Product Code
- CIX FDA UDI
- GMDN Term
- Albumin IVD, kit, nephelometry/turbidimetry 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, nephelometry/turbidimetry
Atellica CH 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, nephelometry/turbidimetry.
- Optilite Albumin Kit — The Binding Site Group · Class II
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- 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
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- Tinaquant Albumin — Roche Diagnostics Corp. · Class I
Cleared under the same submission
K991576 also covers:
- ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated — Siemens Healthcare Diagnostics
- ADVIA® Chemistry ALB Albumin BCG Reagents — Siemens Healthcare Diagnostics
- ADVIA® Chemistry AMY Amylase Reagents — Siemens Healthcare Diagnostics
- ADVIA® Chemistry AMY Amylase Reagents — Siemens Healthcare Diagnostics
- ADVIA® Chemistry AST(GOT) Reagents — Siemens Healthcare Diagnostics
- ADVIA® Chemistry Albumin, ALB_c Albumin Reagents, Concentrated — Siemens Healthcare Diagnostics
- ADVIA® Chemistry Aspartate Aminotransferase (AST) Reagents — Siemens Healthcare Diagnostics
- ADVIA® Chemistry CPC Calcium Reagents — Siemens Healthcare Diagnostics
- ADVIA® Chemistry CREA_2 Creatinine Reagents — Siemens Healthcare Diagnostics
- ADVIA® Chemistry CRE_2c Creatinine Reagents, Concentrated — Siemens Healthcare Diagnostics
- ADVIA® Chemistry Calcium Reagents — Siemens Healthcare Diagnostics
- ADVIA® Chemistry Calcium Reagents, Concentrated (CA_c)-CPC — 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 28540898-68e1-4a50-9287-4365d04358b4 37 fields · synced May 30, 2026