Identity
- Trade Name
- TENDIGO FDA UDI
- Generic Name
- Blot processor IVD FDA UDI
- Device Name
- Instrument FDA UDI
- Model / Reference
- 80412 FDA UDI
- Description
- Instrument FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05414470804122 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Blot processor IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 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
Dimensions & Sizes
- Size
- Length — 27 Inch FDA UDIWidth — 18 Inch FDA UDIHeight — 15 Inch FDA UDI
Category: Blot processor IVD
Tendigo by Fujirebio Europe — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blot processor IVD.
- PROFI BLOT 48 — Tecan Austria GmbH · 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
- Fujirebio Europe
Sources (1)
- FDA UDI 023d5073-6e02-4b57-9305-b23b2d5bf104 36 fields · synced May 30, 2026