Identity
- Trade Name
- TintoEDTA, 1L FDA UDI
- Generic Name
- Immunohistochemistry antigen retrieval reagent IVD FDA UDI
- Device Name
- TintoEDTA is intended to be used with heat-induced epitope or nucleic acid retrieval procedures to permeabilize tissues for Immunohistochemistry (IHC), Immunocytochemistry (ICC), Immunofluorescence (IF) and in situ hybridization (ISH) of nucleic acids (both CISH or FISH) on the TintoStainer Plus automated platform. FDA UDI
- Model / Reference
- BSB-7460 FDA UDI
- Description
- TintoEDTA is intended to be used with heat-induced epitope or nucleic acid retrieval procedures to permeabilize tissues for Immunohistochemistry (IHC), Immunocytochemistry (ICC), Immunofluorescence (IF) and in situ hybridization (ISH) of nucleic acids (both CISH or FISH) on the TintoStainer Plus automated platform. FDA UDI
Identifiers
- Catalog Number
- BSB-7460 FDA UDI
- Primary DI / UDI-DI
- B502BSB74600 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Immunohistochemistry antigen retrieval 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
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
Dimensions & Sizes
- Size
- Total Volume — 1000 Milliliter FDA UDI
Category: Immunohistochemistry antigen retrieval reagent IVD
TintoEDTA, 1L by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Bio Sb, Inc.
Sources (1)
- FDA UDI 4904b574-d8a0-4b36-9ef5-5b0b7d8ae0f4 37 fields · synced May 31, 2026