Identity
- Trade Name
- Automation Tween 20, 20X FDA UDI
- Generic Name
- Immunohistochemistry wash buffer reagent IVD FDA UDI
- Device Name
- Alternate name : 20% Tween 20 FDA UDI
- Model / Reference
- TWA20M FDA UDI
- Description
- Alternate name : 20% Tween 20 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627014627 FDA UDI
- FDA Product Code
- JCC FDA UDI
- GMDN Term
- Immunohistochemistry wash buffer reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
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: Immunohistochemistry wash buffer reagent IVD
Automation Tween 20, 20X by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Immunohistochemistry wash buffer reagent IVD.
- IHC — Slmp, LLC · Class I
- IHC — Slmp, LLC · Class I
- IMMUNO CONCEPTS RELISA® Test Systems — IMMUNO CONCEPTS INC
- DxSelect™ - 10X Wash Buffer — DiaSorin Molecular LLC · Class II
- Drew Scientific — Drew Scientific , Ltd. · Class I
- BioCode MDx 3000 Buffer A — Applied BioCode, Inc.
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Immunocare PBS 10X — BIOCARE MEDICAL, LLC · 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
- Biocare Medical, Llc
Sources (1)
- FDA UDI 2f7f1a0c-2fd0-4203-8688-61f0c90d8d51 34 fields · synced May 30, 2026