FDA.report

Genemed®

Primary DI
00615233005502
Brand
Genemed®
Company
SAKURA FINETEK U.S.A., INC.
Model
52-0006
Catalog number
52-0006
Device description
Power-Stain™ 2.0 Poly HRP Kit for Mouse + Rabbit, Ready-To-Use, 15 mL each
Published
2019-12-28
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
00615233005502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00615233005502006152330055026152330055020615233005502

GMDN Terms

TermDefinition
Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistryA collection of reagents and other associated materials intended to be used for the discrete visualisation of immune complexes bound to specific cellular markers in a clinical specimen. Sustrates are used to detect immunoperoxidase-bound complexes and may include diaminobenzidine (DAB), aminoethylcarbazole (AEC), nitro blue tetrazolium/bromochloroindolyl phosphate (NBT/BCIP) and/or fast red using an enzyme immunohistochemistry method.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(310)972-7800TS@sakuraus.com

Regulatory Flags

DUNS number
179135769
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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