FDA.reportPublic FDA data

Anti-KRAS

Primary DI
00810119672421
Brand
Anti-KRAS
Company
BIOGENEX LABORATORIES
Model
AR751-5R
Catalog number
AR751-5R
Published
2026-09-18
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
00810119672421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810119672421008101196724218101196724210810119672421

GMDN Terms#

Term, Definition table
TermDefinition
KRAS gene mutation IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative detection of the KRAS (v-ki-ras2 kirsten rat sarcoma viral oncogene homolog) mutation status and/or to evaluate a clinical specimen to predict or monitor the response to treatment with epidermal growth factor receptor (EGFR) inhibitors by determining the KRAS mutation status of tumour tissue using a nucleic acid technique (NAT).

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
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
00840542210259Anti-CD53AN734-10MAN734-10M2026-09-18
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
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
00840542210259Anti-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