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ADVIA® Chemistry CRE_2c Creatinine Reagents, Concentrated
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- ADVIA® Chemistry CRE_2c Creatinine Reagents, Concentrated FDA UDI
- Generic Name
- Creatinine IVD, kit, spectrophotometry FDA UDI
- Device Name
- Creatinine Jaffe - ADVIA Chem. - Conc. RGT - 4x2360 tests FDA UDI
- Model / Reference
- 10283346 FDA UDI
- Description
- Creatinine Jaffe - ADVIA Chem. - Conc. RGT - 4x2360 tests FDA UDI
Identifiers
- Catalog Number
- 6860515 FDA UDI
- Primary DI / UDI-DI
- 00630414553184 FDA UDI
- 510(k) Number
- K991576 FDA UDI
- FDA Product Code
- CGX FDA UDI
- GMDN Term
- Creatinine IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1225 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: Creatinine IVD, kit, spectrophotometry
ADVIA® Chemistry CRE_2c Creatinine Reagents, Concentrated by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Creatinine IVD, kit, spectrophotometry.
- CREATININE-S Assay — Sekisui Diagnostics, LLC · Class II
- Creatinine Jaff method — Roche Diagnostics Corp. · Class II
- Yumizen C1200 Creatinine Jaffé — Horiba Abx · Class II
- Carolina Liquid Chemistries Corp. Basic Multi-Drug Control Set — Carolina Liquid Chemistries Corp. · Class I
- Diazyme — Diazyme Laboratories, Inc.
- CREATININE (CREA) — Randox Laboratories, Ltd. · Class II
- Creatinine Jaff Gen2 — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
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 Calcium Reagents — Siemens Healthcare Diagnostics
- ADVIA® Chemistry Calcium Reagents, Concentrated (CA_c)-CPC — Siemens Healthcare Diagnostics
- ADVIA® Chemistry IP Inorganic Phosphorus Reagents — 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 6d61837b-4fa1-4101-a4ab-8dc3fc2cd83e 37 fields · synced May 30, 2026