Identity
- Trade Name
- Dimension® Flex® reagent cartridge CKI FDA UDI
- Generic Name
- Total creatine kinase (CK) IVD, kit, spectrophotometry FDA UDI
- Device Name
- Creatine Kinase Flex® reagent cartridge, 480 tests FDA UDI
- Model / Reference
- 10464511 FDA UDI
- Description
- Creatine Kinase Flex® reagent cartridge, 480 tests FDA UDI
Identifiers
- Catalog Number
- DF38 FDA UDI
- Primary DI / UDI-DI
- 00842768025525 FDA UDI
- 510(k) Number
- K081731 FDA UDI
- FDA Product Code
- JHS FDA UDI
- GMDN Term
- Total creatine kinase (CK) IVD, kit, 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, spectrophotometry
Dimension® 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, spectrophotometry.
Cleared under the same submission
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 fecb9393-53be-4c81-bf02-a1425fa6e8c6 37 fields · synced Jun 6, 2026