FDA.reportPublic FDA data

ENHANCED ANTIBODY DILUENT

Primary DI
00810119679857
Brand
ENHANCED ANTIBODY DILUENT
Company
BIOGENEX LABORATORIES
Model
HK941-YAK
Catalog number
HK941-YAK
Published
2023-05-18
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
00810119679857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810119679857008101196798578101196798570810119679857

GMDN Terms#

Term, Definition table
TermDefinition
Immunohistochemistry antibody diluent IVDA substance or reactant intended to be used for the dilution of antibody solution for use in an enzyme immunohistochemistry assay performed on biological tissues or clinical specimens.

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
05055331340900BONDLEICA BIOSYSTEMS NEWCASTLE LTDNJT2026-09-25
05055331340917BONDLEICA BIOSYSTEMS NEWCASTLE LTDNJT2026-09-25
00810119671912Anti-HIF-1 alphaBIOGENEX LABORATORIESNJT2026-09-22
00810119672926Anti-Heat Shock Protein 27 (HSP 27)BIOGENEX LABORATORIESNJT2026-09-22
00810119673206Anti-Collagen IIIBIOGENEX LABORATORIESNJT2026-09-22
00810119674463Anti-Beta-Tubulin IIBIOGENEX LABORATORIESNJT2026-09-22
00810119674531Anti-Beta-Tubulin IVBIOGENEX LABORATORIESNJT2026-09-22
00810119675996Anti-Beta-Tubulin IVBIOGENEX LABORATORIESNJT2026-09-22
00810119676016Anti-Beta-Tubulin IIIBIOGENEX LABORATORIESNJT2026-09-22
00810119679000Anti-Collagen IIIBIOGENEX LABORATORIESNJT2026-09-22
00810119679277Anti-Beta-Tubulin IVBIOGENEX LABORATORIESNJT2026-09-22
00840542202629Anti-Alpha-TubulinBIOGENEX LABORATORIESNJT2026-09-22
00840542202636Anti-Alpha-TubulinBIOGENEX LABORATORIESNJT2026-09-22
00840542202650Anti-Alpha-TubulinBIOGENEX LABORATORIESNJT2026-09-22
00840542202667Anti-Alpha-TubulinBIOGENEX LABORATORIESNJT2026-09-22
00840542203138Anti-CDw75 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203145Anti-CDw75 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203152Anti-CDw75 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203169Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203176Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203183Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203190Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203206Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203213Anti-CD74 (B cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203268Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203275Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203282Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203299Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203305Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22
00840542203312Anti-CD45RC (T Cell)BIOGENEX LABORATORIESNJT2026-09-22