FDA.reportPublic FDA data

Anti-CD53

Primary DI
00840542210259
Brand
Anti-CD53
Company
BIOGENEX LABORATORIES
Model
AN734-10M
Catalog number
AN734-10M
Published
2026-09-18
Public version status
New
Distribution status
Not 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
00840542210259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840542210259008405422102598405422102590840542210259

GMDN Terms#

Term, Definition table
TermDefinition
Multiple CD cell marker 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 multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumeration of specific cell populations.

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
00810119672421Anti-KRASAR751-5RAR751-5R2026-09-18
00840542207594Anti-CD2AM438-10MAM438-10M2026-09-18
00840542207600Anti-CD2AX438-50DAX438-50D2026-09-18
00840542207693Anti-Inhibin-AlphaAM446-10MAM446-10M2026-09-18
00840542207709Anti-Inhibin-AlphaAX446-50DAX446-50D2026-09-18
00840542207716Anti-Inhibin-AlphaAX446-YCDAX446-YCD2026-09-18
00840542210181Anti-CD90AN733-5MAN733-5M2026-09-18
00840542210198Anti-CD90AN733-10MAN733-10M2026-09-18
00840542210204Anti-CD90AY733-50DAY733-50D2026-09-18
00840542210211Anti-CD90AY733-YCDAY733-YCD2026-09-18
00840542210228Anti-CD90NU733-UCNU733-UC2026-09-18
00840542210235Anti-CD90NU733-5UCNU733-5UC2026-09-18
00840542210242Anti-CD53AN734-5MAN734-5M2026-09-18
00840542210266Anti-CD53AY734-50DAY734-50D2026-09-18
00840542210372Anti-CD205AN737-10MEAN737-10ME2026-09-18
00840542210389Anti-CD205AY737-50DEAY737-50DE2026-09-18
00840542210396Anti-CD205AY737-YCDEAY737-YCDE2026-09-18
00840542210402Anti-CD205NU737-UCENU737-UCE2026-09-18
00840542210419Anti-CD205NU737-5UCENU737-5UCE2026-09-18
00840542210426Anti-CD103AN739-5MEAN739-5ME2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810119672421Anti-KRASBIOGENEX LABORATORIESNJT2026-09-18
00840542207594Anti-CD2BIOGENEX LABORATORIESNJT2026-09-18
00840542207600Anti-CD2BIOGENEX LABORATORIESNJT2026-09-18
00840542207693Anti-Inhibin-AlphaBIOGENEX LABORATORIESNJT2026-09-18
00840542207709Anti-Inhibin-AlphaBIOGENEX LABORATORIESNJT2026-09-18
00840542207716Anti-Inhibin-AlphaBIOGENEX LABORATORIESNJT2026-09-18
00840542210181Anti-CD90BIOGENEX LABORATORIESNJT2026-09-18
00840542210198Anti-CD90BIOGENEX LABORATORIESNJT2026-09-18
00840542210204Anti-CD90BIOGENEX LABORATORIESNJT2026-09-18
00840542210211Anti-CD90BIOGENEX LABORATORIESNJT2026-09-18
00840542210228Anti-CD90BIOGENEX LABORATORIESNJT2026-09-18
00840542210235Anti-CD90BIOGENEX LABORATORIESNJT2026-09-18
00840542210242Anti-CD53BIOGENEX LABORATORIESNJT2026-09-18
00840542210266Anti-CD53BIOGENEX LABORATORIESNJT2026-09-18
00840542210426Anti-CD103BIOGENEX LABORATORIESNJT2026-09-18
00840542210433Anti-CD103BIOGENEX LABORATORIESNJT2026-09-18
00840542210457Anti-CD103BIOGENEX LABORATORIESNJT2026-09-18
00840542210464Anti-CD103BIOGENEX LABORATORIESNJT2026-09-18
00840542210945ANTI-KRASBIOGENEX LABORATORIESNJT2026-09-18
00840542210952ANTI-KRASBIOGENEX LABORATORIESNJT2026-09-18
00840542211201Anti-CD82BIOGENEX LABORATORIESNJT2026-09-18
00840542211218Anti-CD82BIOGENEX LABORATORIESNJT2026-09-18
00840542223280Anti-Inhibin AlphaBIOGENEX LABORATORIESNJT2026-09-18
00841683151340Arginase-1 SP156 Rab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151364CD163 MRQ-26 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151371Cytokeratin 5 & 6 D5 & 16B4 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151388Ep-CAM MOC31 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151395GATA3 L50-823 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151401Glypican-3 1G12 Mab.CELL MARQUE CORPORATIONNJT2026-09-04
00841683151418Hepatocyte Specific Antigen (Hep-Par 1) OCH1E5 Mab.CELL MARQUE CORPORATIONNJT2026-09-04