Identity
- Trade Name
- StatLab FDA UDI
- Generic Name
- General specimen microscopy slide IVD, single-use FDA UDI
- Model / Reference
- Millennia ground egdes yellow marking area FDA UDI
Identifiers
- Catalog Number
- 318Y FDA UDI
- Primary DI / UDI-DI
- 04250317357427 FDA UDI
- FDA Product Code
- KEW FDA UDI
- GMDN Term
- General specimen microscopy slide IVD, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General specimen microscopy slide IVD, single-use
StatLab by Paul Marienfeld GmbH & Co. KG — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Paul Marienfeld GmbH & Co. KG
Sources (1)
- FDA UDI 2c1e0f2d-2e72-4bd7-93e3-5ea5ddd2f2d9 33 fields · synced Jun 9, 2026