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TBS Auto Wash Buffer 40X
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref TWB946L2JModel Wash Buffers for IHC
Identity
- Trade Name
- TBS Automation Wash Buffer, 40X EUDAMEDTBS Auto Wash Buffer 40X FDA UDI
- Generic Name
- Buffered wash solution IVD FDA UDI
- Device Name
- Wash Buffers for IHC EUDAMED
- Model / Reference
- TWB946L2J EUDAMEDFDA UDIWash Buffers for IHC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847627014658 EUDAMEDFDA UDI
- Basic UDI-DI
- 08476270BWASHBUF3Q EUDAMED
- FDA Product Code
- JCC FDA UDI
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Buffered wash solution IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
TBS Auto Wash Buffer 40X by Biocare Medical, Llc — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- ADVIA Centaur® PW 4 — Siemens Healthcare Diagnostics · Class I
- COBAS® AMPLICOR Wash Buffer — Roche Molecular Systems, Inc.
- ISE Buffer Reagent — DIAMOND DIAGNOSTICS Inc
- ADVIA Centaur® Wash 1 — Siemens Healthcare Diagnostics · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biocare Medical, Llc
Sources (2)
- FDA UDI 1d610888-95d9-46e8-b3fa-da69e78a8160 33 fields · synced Aug 1, 2026
- EUDAMED 3f4fb289-ed50-4a40-9245-27b6f2ee954e 61 fields · synced Aug 1, 2026