Identity
- Trade Name
- Dimension Vista® Flex® reagent cartridge CKI FDA UDI
- Generic Name
- Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry FDA UDI
- Device Name
- Creatine Kinase Flex® reagent cartridge, 800 Tests FDA UDI
- Model / Reference
- 10464356 FDA UDI
- Description
- Creatine Kinase Flex® reagent cartridge, 800 Tests FDA UDI
Identifiers
- Catalog Number
- K2038 FDA UDI
- Primary DI / UDI-DI
- 00842768027925 FDA UDI
- 510(k) Number
- K083465 FDA UDI
- FDA Product Code
- CGS FDA UDI
- GMDN Term
- Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1215 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: Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
Dimension Vista® Flex® reagent cartridge CKI by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry.
- Pointe Scientific, Inc. Creatine Kinase — POINTE SCIENTIFIC, INC. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Creatine Kinase liquid, acc. to IFCC — Roche Diagnostics Corp. · Class II
- POINTE SCIENTIFIC CK (Liquid) — POINTE SCIENTIFIC, INC. · Class II
- Sirrus® CK Liqui-UV® — STANBIO LABORATORY, L.P. · Class II
- Creatine Kinase — Roche Diagnostics Corp. · Class II
- CK Liqui-UV® — STANBIO LABORATORY, L.P. · Class II
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
Cleared under the same submission
K083465 also covers:
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 531635dd-10a3-484e-9a35-4ef315e357c8 37 fields · synced May 30, 2026