FDA.reportPublic FDA data

AEC Substrate Pack

Primary DI
00850646007334
Brand
AEC Substrate Pack
Company
BIOGENEX LABORATORIES
Model
HK129-5KE
Catalog number
HK129-5KE
Published
2023-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850646007334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850646007334008506460073348506460073340850646007334

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at 2-8°C

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 421-4149support@biogenex.com

Regulatory Flags#

DUNS number
042697045
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810119676733ANTI-HER2/ERBB2AY726-YCDAY726-YCD2023-05-04
00810119679062ANTI-C-ERBB-2NU753-UCNU753-UC2023-04-25
00810119677433Anti- HER2/ERBB2 PHOSPHO (PY877)NU726-UCNU726-UC2023-04-21
00810119676443ANTI-HER2/ERBB2AN726-5MAN726-5M2023-04-20
00810119674395ANTI- HER2/ERBB2NU726-5UCNU726-5UC2023-04-19
00810119674562ANTI-C-ERBB-2 (HER-2/NEU)MU134-5UCMU134-5UC2023-04-19
00810119674890ANTI- HER2/ERBB2NU726-UCNU726-UC2023-04-19
00810119673541ANTI-C-ERBB-2 (HER-2/NEU)MU134-5UCMU134-5UC2023-04-18
00810119671363ANTI-C-ERBB-2 (HER-2/NEU)AM134-5MAM134-5M2023-04-03
00810119674876ANTI-C-ERBB-2 (HER-2/NEU)MU134-UCMU134-UC2023-03-29
00810119670069ANTI-HER2/ERBB2AN726-5MAN726-5M2023-03-28
00810119670373ANTI-C-ERBB-2 (HER-2/NEU)AM134-5MAM134-5M2023-03-28
00810119670168ANTI-HER2/ERBB2AN726-10MAN726-10M2023-03-27
00810119673923ANTI-VIPAR530-5RAR530-5R2023-05-12
00810119678713ANTI-VIPPU530-UPPU530-UP2023-04-24
00810119673169ANTI-TAUAM412-5MAM412-5M2023-04-17
00810119672513ANTI-TAUAM459-5MAM459-5M2023-04-06
00810119671202ANTI-BETA-HCGAM395-5MAM395-5M2023-03-31
00810119673411TRIS WASH BUFFERHK098-5KHK098-5K2023-05-12
00850646007341DiluentHK156-5KEHK156-5KE2023-05-19

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