Identity
- Trade Name
- ProciseDx Calibration Cartridge FDA UDI
- Generic Name
- Optical laboratory instrument performance standard calibrator/control IVD, reusable FDA UDI
- Device Name
- The ProciseDx Calibration Cartridge is an accessory with quantitative assigned values to the ProciseDx Analyzer and is used to confirm that the instrument is operating within specified limits. The calibration cartridge does not contact biological specimens and is not used for diagnostic testing. The intended users are clinical laboratory professionals responsible for completing a periodic calibration check of the ProciseDx Analyzer. FDA UDI
- Model / Reference
- 5429 FDA UDI
- Description
- The ProciseDx Calibration Cartridge is an accessory with quantitative assigned values to the ProciseDx Analyzer and is used to confirm that the instrument is operating within specified limits. The calibration cartridge does not contact biological specimens and is not used for diagnostic testing. The intended users are clinical laboratory professionals responsible for completing a periodic calibration check of the ProciseDx Analyzer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08100322954295 FDA UDI
- FDA Product Code
- DCK FDA UDI
- GMDN Term
- Optical laboratory instrument performance standard calibrator/control IVD, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5270 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, reusable
ProciseDx Calibration Cartridge by Chembio Diagnostic Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Chembio Diagnostic Systems
Sources (1)
- FDA UDI 540727be-3b7f-4841-b8cd-63222b6425f7 34 fields · synced May 30, 2026