Identity
- Trade Name
- PROFI BLOT 48 FDA UDI
- Generic Name
- Blot processor IVD FDA UDI
- Model / Reference
- 09120052070507 FDA UDI
Identifiers
- Catalog Number
- 30087537 FDA UDI
- Primary DI / UDI-DI
- 09120052070507 FDA UDI
- FDA Product Code
- KPA FDA UDI
- GMDN Term
- Blot processor IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3800 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
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: Blot processor IVD
Profi Blot 48 by Tecan Austria GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blot processor IVD.
- TENDIGO — Fujirebio Europe · Class I
- PROFI BLOT T48 — Tecan Austria GmbH · 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 |
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Manufacturer
- Manufacturer
- Tecan Austria GmbH
Sources (1)
- FDA UDI e5eae5c4-4bcf-44d0-bd31-6f7ac7201386 34 fields · synced May 30, 2026