Identity
- Trade Name
- V8 Maintenance Buffer Kit FDA UDI
- Generic Name
- Buffered wash solution IVD FDA UDI
- Model / Reference
- 1832 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M52518320 FDA UDI
- FDA Product Code
- CEF FDA UDI
- GMDN Term
- Buffered wash solution IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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 IVD
V8 Maintenance Buffer Kit by Helena Laboratories, Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Buffered wash solution IVD.
- ADVIA Centaur® Wash 1 — Siemens Healthcare Diagnostics · Class I
- ADVIA Centaur® PW3 — Siemens Healthcare Diagnostics · Class I
- CELL-DYN — Abbott Laboratories, Inc. · Class I
- VENTANA HE 600 Wash — Ventana Medical Systems · Class I
- TBS Auto Wash Buffer 20X — BIOCARE MEDICAL, LLC · Class I
- ADVIA Centaur® PW 4 — Siemens Healthcare Diagnostics · Class I
- COBAS® AMPLICOR Wash Buffer — Roche Molecular Systems, Inc.
- ISE Buffer Reagent — DIAMOND DIAGNOSTICS Inc
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
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI dbd47e93-5f8a-4336-b8f5-b3947cfff8c5 33 fields · synced Jun 9, 2026