Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Buffered wash solution IVD FDA UDI
- Device Name
- ARCHITECT CONCENTRATED WASH BUFFER (10L) FDA UDI
- Model / Reference
- 6C54-88 FDA UDI
- Description
- ARCHITECT CONCENTRATED WASH BUFFER (10L) FDA UDI
Identifiers
- Catalog Number
- 06C5488 FDA UDI
- Primary DI / UDI-DI
- 00380740009618 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Buffered wash solution 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
Yes
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
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
Architect by Abbott Ireland Diagnostics — 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
- Abbott Ireland Diagnostics
Sources (1)
- FDA UDI d10896d5-24eb-48f0-80da-459a71bcdafc 36 fields · synced May 30, 2026