FDA.reportPublic FDA data

Anti-CDw75 (B cell)

Primary DI
00840542203145
Brand
Anti-CDw75 (B cell)
Company
BIOGENEX LABORATORIES
Model
AX152-50D
Catalog number
AX152-50D
Published
2026-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00840542203145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840542203145008405422031458405422031450840542203145

GMDN Terms#

Term, Definition table
TermDefinition
B lymphocyte 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 B lymphocytes in a clinical specimen.

Regulatory Flags#

DUNS number
042697045
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

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
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
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
00840542203329Anti-B CellBIOGENEX LABORATORIESNJT2026-09-22
00840542203336Anti-B CellBIOGENEX LABORATORIESNJT2026-09-22
00840542203343Anti-B CellBIOGENEX LABORATORIESNJT2026-09-22