FDA.reportPublic FDA data

ANTI-C-ERBB-2 (HER-2/NEU)

Primary DI
00810119671363
Brand
ANTI-C-ERBB-2 (HER-2/NEU)
Company
BIOGENEX LABORATORIES
Model
AM134-5M
Catalog number
AM134-5M
Published
2023-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810119671363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810119671363008101196713638101196713630810119671363

GMDN Terms#

Term, Definition table
TermDefinition
C-erbB2/Her2/neu oncoprotein IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of c-erbB2 oncoprotein, also known as Her2 or neu oncoprotein, in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume6Milliliter

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
00810119671912Anti-HIF-1 alphaANB27-5MANB27-5M2026-09-22
00810119672926Anti-Heat Shock Protein 27 (HSP 27)AM171-5MAM171-5M2026-09-22
00810119673206Anti-Collagen IIIAM167-5MAM167-5M2026-09-22
00810119674463Anti-Beta-Tubulin IIMU176-5UCMU176-5UC2026-09-22
00810119674531Anti-Beta-Tubulin IVMU178-5UCMU178-5UC2026-09-22
00810119675996Anti-Beta-Tubulin IVMU178-UCMU178-UC2026-09-22
00810119676016Anti-Beta-Tubulin IIIMU177-UCMU177-UC2026-09-22
00810119679000Anti-Collagen IIIMU167-UCMU167-UC2026-09-22
00810119679277Anti-Beta-Tubulin IVAM178-10MAM178-10M2026-09-22
00840542202094Anti-Hepatitis B Virus Core Antigen (HBcAg)AW082-YCDEAW082-YCDE2026-09-22
00840542202100Anti-Hepatitis B Virus Core Antigen (HBcAg)PU082-UPEPU082-UPE2026-09-22
00840542202117Anti-Hepatitis B Virus Core Antigen (HBcAg)PU082-5UPEPU082-5UPE2026-09-22
00840542202186Anti-Herpes Simplex Virus Type II (HSV II)AR085-5REAR085-5RE2026-09-22
00840542202193Anti-Herpes Simplex Virus Type II (HSV II)AR085-10REAR085-10RE2026-09-22
00840542202209Anti-Herpes Simplex Virus Type II (HSV II)AW085-50DEAW085-50DE2026-09-22
00840542202216Anti-Herpes Simplex Virus Type II (HSV II)AW085-YCDEAW085-YCDE2026-09-22
00840542202223Anti-Herpes Simplex Virus Type II (HSV II)PU085-UPEPU085-UPE2026-09-22
00840542202230Anti-Herpes Simplex Virus Type II (HSV II)PU085-5UPEPU085-5UPE2026-09-22
00840542202629Anti-Alpha-TubulinAM121-5MAM121-5M2026-09-22
00840542202636Anti-Alpha-TubulinAM121-10MAM121-10M2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382906718167HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718174HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718181HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718198HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718204HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718211HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718235HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718242HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718259HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718266HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718273HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718280HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718310HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718327HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718334HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718341HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718358Not ApplicableBecton, Dickinson And CompanyMVU2026-09-24
00382906718365HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718372HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718389HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718396HorizonBecton, Dickinson And CompanyMVU2026-09-24
00840542202094Anti-Hepatitis B Virus Core Antigen (HBcAg)BIOGENEX LABORATORIESMVU2026-09-22
00840542202100Anti-Hepatitis B Virus Core Antigen (HBcAg)BIOGENEX LABORATORIESMVU2026-09-22
00840542202117Anti-Hepatitis B Virus Core Antigen (HBcAg)BIOGENEX LABORATORIESMVU2026-09-22
00840542202186Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202193Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202209Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202216Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202223Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202230Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22