Identity
- Trade Name
- StatLab FDA UDI
- Generic Name
- General specimen microscopy slide IVD, single-use FDA UDI
- Model / Reference
- Histobond+ ground edges clipped corners tan marking area FDA UDI
Identifiers
- Catalog Number
- 418T/45 FDA UDI
- Primary DI / UDI-DI
- 04250317360922 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
Similar devices
Also classified as General specimen microscopy slide IVD, single-use.
- KT ™ Premium Slides — Slmp, LLC · Class I
- Non-Adhesion Microscope Slide — New Erie Scientific LLC · Class A
- Non-Adhesion Microscope Slide — New Erie Scientific LLC · Class A
- RANKIN — Yancheng Jingwei Chemicals Co., Ltd · Class I
- Non-Adhesion Microscope Slide — New Erie Scientific LLC · Class A
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- CANCER — Yancheng Jingwei Chemicals Co., Ltd · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Paul Marienfeld GmbH & Co. KG
Sources (1)
- FDA UDI 6d72adc8-6ce4-4275-9b3f-72d57d9a3035 33 fields · synced Jun 9, 2026