Identity
- Trade Name
- DensiCHEK™ CALIBRATION STANDARD FDA UDI
- Generic Name
- Optical laboratory instrument performance standard calibrator/control IVD, reusable FDA UDI
- Device Name
- These are calibration standards for the DensiCHEK™ Plus instrument which is designed for use with the VITEK®2 to measure the optical density of a bacterial suspension. FDA UDI
- Model / Reference
- DensiCHEK™ CALIBRATION STANDARD FDA UDI
- Description
- These are calibration standards for the DensiCHEK™ Plus instrument which is designed for use with the VITEK®2 to measure the optical density of a bacterial suspension. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026551155 FDA UDI
- 510(k) Number
- K083536 FDA UDI
- FDA Product Code
- LON FDA UDI
- GMDN Term
- Optical laboratory instrument performance standard calibrator/control IVD, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1645 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
Yes
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
DensiCHEK™ CALIBRATION STANDARD by Biomerieux , Inc. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K083536 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biomerieux , Inc.
Sources (2)
- FDA UDI 40051d02-e918-43e4-9167-3c1ff9f26f9d 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026