Identity
- Trade Name
- Dimension® Flex® reagent cartridge CHK FDA UDI
- Generic Name
- Optical laboratory instrument performance standard calibrator/control IVD, single-use FDA UDI
- Device Name
- CHK Flex® reagent cartridge, 8 Flex® reagent cartridges FDA UDI
- Model / Reference
- 10481507 FDA UDI
- Description
- CHK Flex® reagent cartridge, 8 Flex® reagent cartridges FDA UDI
Identifiers
- Catalog Number
- DF179 FDA UDI
- Primary DI / UDI-DI
- 00842768033124 FDA UDI
- 510(k) Number
- K862359 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Optical laboratory instrument performance standard calibrator/control IVD, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 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: Optical laboratory instrument performance standard calibrator/control IVD, single-use
Dimension® Flex® reagent cartridge CHK by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Optical laboratory instrument performance standard calibrator/control IVD, single-use.
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Cleared under the same submission
K862359 also covers:
- Dimension® Flex® reagent cartridge T4 — Siemens Healthcare Diagnostics
- Dimension® Flex® reagent cartridge TU — Siemens Healthcare Diagnostics
- Dimension® Flex® reagent cartridge URCA — Siemens Healthcare Diagnostics
- Dimension® T4 Calibrator — Siemens Healthcare Diagnostics
- Dimension® TU Calibrator — 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 d96b70e3-1bdf-4f8b-bff0-54171c6dce71 37 fields · synced May 30, 2026