FDA.report

TintoEDTA, 1L

Primary DI
B502BSB74600
Brand
TintoEDTA, 1L
Company
BIO SB, INC.
Model
BSB-7460
Catalog number
BSB-7460
Device 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.
Published
2025-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
PPMGeneral purpose reagent

Product Code Classifications

CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B502BSB74600PrimaryHIBCC0

GMDN Terms

TermDefinition
Immunohistochemistry antigen retrieval reagent IVDA substance or reactant intended to be used for the non-enzymatic retrieval of antigenic epitopes from biological tissues or clinical specimen, using an enzyme immunohistochemistry assay.

Device Sizes

TypeValueUnit
Total Volume1000Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)561-1145sales@biosb.com

Regulatory Flags

DUNS number
102855447
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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