Identity
- Trade Name
- Tissue-Tek Genie® FDA UDI
- Generic Name
- Immunoassay reagent vehicle tray IVD, reusable FDA UDI
- Device Name
- User-Fillable Capsule Tray, 2/box FDA UDI
- Model / Reference
- 8611-G002 FDA UDI
- Description
- User-Fillable Capsule Tray, 2/box FDA UDI
Identifiers
- Catalog Number
- 8611-G002 FDA UDI
- Primary DI / UDI-DI
- 00615233002761 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Immunoassay reagent vehicle tray IVD, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Immunoassay reagent vehicle tray IVD, reusable
Tissue-Tek Genie® by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Immunoassay reagent vehicle tray IVD, reusable.
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
- Sakura Finetek USA, Inc
Sources (1)
- FDA UDI 843151a8-3859-4a63-825d-8da09c1c39b2 35 fields · synced May 30, 2026