Identity
- Trade Name
- DIGIVAL Tray Pack 1 FDA UDI
- Generic Name
- Immunoassay reagent vehicle tray IVD, reusable FDA UDI
- Device Name
- A tray insert to be used with the DIGIVAL to ensure correct placement of the immunoassay reagent vehicle (e.g., test strip, cassette, or card). FDA UDI
- Model / Reference
- LFR-004 FDA UDI
- Description
- A tray insert to be used with the DIGIVAL to ensure correct placement of the immunoassay reagent vehicle (e.g., test strip, cassette, or card). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10811877011214 FDA UDI
- 510(k) Number
- K162642 FDA UDI
- GMDN Term
- Immunoassay reagent vehicle tray IVD, reusable FDA UDI
Classification
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Immunoassay reagent vehicle tray IVD, reusable
DIGIVAL Tray Pack 1 by Alere Scarborough, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Immunoassay reagent vehicle tray IVD, reusable.
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Tissue-Tek® — Sakura Finetek USA, Inc · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Tissue-Tek® Paraform® — Sakura Finetek USA, Inc · Class I
- Alere Reader BinaxNOW Tray Pack — Alere Scarborough, Inc.
Cleared under the same submission
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alere Scarborough, Inc.
Sources (1)
- FDA UDI 05547e76-6d68-49a0-af07-e9299dd74577 34 fields · synced May 30, 2026