FDA.reportPublic FDA data

PAX-8 (SP348) Rabbit Monoclonal Antibody

Primary DI
07613336231395
Brand
PAX-8 (SP348) Rabbit Monoclonal Antibody
Company
Ventana Medical Systems, Inc.
Model
10272589001
Catalog number
10272589001
Published
2026-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
07613336231395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336231395076133362313957613336231395

GMDN Terms#

Term, Definition table
TermDefinition
Paired box protein (PAX) 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 a paired box protein (PAX) [e.g., PAX2, PAX8], a homeobox transcription factor, in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184042521
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
04015630967162ISH Peroxidase Inhibitor07729014001077290140012026-07-13
07613336239025VENTANA MTAP (SP530) Rabbit Monoclonal Antibody10574518001105745180012026-06-08
07613336236987VENTANA CD15 (MMA.P8) Mouse Monoclonal Antibody10496410001104964100012026-05-18
07613336239063Congo Red Stain Core Kit10585021001105850210012026-04-10
07613336239544Gram Stain Core Kit10608358001106083580012026-04-10
04015630984787SSR Solution06890059001068900590012021-02-03
07613336226568VENTANA® U6 DIG Probe10062746001100627460012026-03-26
07613336240281ASSY RGT DSPNR CARD BMK PREP KIT 30110637412001106374120012026-03-20
07613336240298ASSY RGT DSPNR CARD BMK PREP KIT 30210637439001106374390012026-03-20
07613336240304ASSY RGT DSPNR CARD BMK PREP KIT 30310637447001106374470012026-03-20
07613336240311ASSY RGT DSPNR CARD BMK PREP KIT 30410637455001106374550012026-03-20
07613336240328ASSY RGT DSPNR CARD BMK PREP KIT 30510637463001106374630012026-03-20
07613336240335ASSY RGT DSPNR CARD BMK PREP KIT 30610637471001106374710012026-03-20
07613336240342ASSY RGT DSPNR CARD BMK PREP KIT 30710637480001106374800012026-03-20
07613336240359ASSY RGT DSPNR CARD BMK PREP KIT 30810637498001106374980012026-03-20
07613336240366ASSY RGT DSPNR CARD BMK PREP KIT 30910637501001106375010012026-03-20
07613336240373ASSY RGT DSPNR CARD BMK PREP KIT 31010637536001106375360012026-03-20
07613336240380ASSY RGT DSPNR CARD BMK PREP KIT 31110637544001106375440012026-03-20
07613336240397ASSY RGT DSPNR CARD BMK PREP KIT 31210637552001106375520012026-03-20
07613336240403ASSY RGT DSPNR CARD BMK PREP KIT 31310637579001106375790012026-03-20

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
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