Identity
- Trade Name
- TRIS WASH BUFFER FDA UDI
- Generic Name
- Buffered wash solution IVD FDA UDI
- Model / Reference
- HK098-5K FDA UDI
Identifiers
- Catalog Number
- HK098-5K FDA UDI
- Primary DI / UDI-DI
- 00810119673411 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Buffered wash solution IVD 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Buffered wash solution IVDBuffered wash solution IVD, manual
Tris Wash Buffer by Biogenex Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Buffered wash solution IVD, manual.
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- Immco — CLARK LABORATORIES, INC. · Class II
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- EUROArray wash buffer set — EUROIMMUN Medizinische Labordiagnostika AG · 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
- Biogenex Laboratories, Inc.
Sources (1)
- FDA UDI 4363ba55-e7f5-4528-98ff-2a75d6877234 35 fields · synced May 30, 2026