Identity
- Trade Name
- Atellica CH Iron_2 FDA UDI
- Generic Name
- Iron IVD, kit, spectrophotometry FDA UDI
- Device Name
- Iron (Iron_2) Atellica CH - RGT 1792T FDA UDI
- Model / Reference
- 11097601 FDA UDI
- Description
- Iron (Iron_2) Atellica CH - RGT 1792T FDA UDI
Identifiers
- Catalog Number
- 11097601 FDA UDI
- Primary DI / UDI-DI
- 00630414596402 FDA UDI
- 510(k) Number
- K991576 FDA UDI
- FDA Product Code
- JIY FDA UDI
- GMDN Term
- Iron IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1410 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: Iron IVD, kit, spectrophotometry
Atellica CH Iron_2 by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K991576 also covers:
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- 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 I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI b5572161-a980-46e0-9269-85cf57f02080 37 fields · synced May 30, 2026