Identity
- Trade Name
- Quebec® Manual Darkfield Colony Counter FDA UDI
- Generic Name
- Colony counter IVD, manual FDA UDI
- Model / Reference
- 13332500 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812559011419 FDA UDI
- FDA Product Code
- KZC FDA UDI
- GMDN Term
- Colony counter IVD, manual FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2180 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Colony counter IVD, manual
Quebec® Manual Darkfield Colony Counter by Reichert Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Colony counter IVD, manual.
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
- Reichert Inc.
Sources (1)
- FDA UDI 405a9891-b6fc-41c0-b302-6fb62fc6b17f 32 fields · synced Jun 6, 2026