FDA.reportPublic FDA data

CONFIRM anti-Melanosome [HMB45] Mouse Monoclonal Primary Antibody

Primary DI
04015630972449
Brand
CONFIRM anti-Melanosome [HMB45] Mouse Monoclonal Primary Antibody
Company
Ventana Medical Systems, Inc.
Model
05479282001
Catalog number
05479282001
Published
2021-01-29
Public version status
Update
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
04015630972449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630972449040156309724494015630972449

GMDN Terms#

Term, Definition table
TermDefinition
Melanosome 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 melanosomes 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
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
07613336240410ASSY RGT DSPNR CARD BMK PREP KIT 31410637587001106375870012026-03-20
07613336240427ASSY RGT DSPNR CARD BMK PREP KIT 31510637595001106375950012026-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336236987VENTANA CD15 (MMA.P8) Mouse Monoclonal AntibodyVentana Medical Systems, Inc.NJT2026-05-18
00847627051622CK HMW + p63 + AMACR (RM)BIOCARE MEDICAL LLCNJT2026-05-14
00847627051639CK HMW + p63 + AMACR (RM)BIOCARE MEDICAL LLCNJT2026-05-14
00846405000005Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-05-01
00846405000012Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-05-01
00846405000029Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-05-01
00847627040664SALL4BIOCARE MEDICAL LLCNJT2026-04-01
00847627041036Cyclin D1BIOCARE MEDICAL LLCNJT2026-04-01
00847627042095Carcinoembryonic Antigen (CEA{M})BIOCARE MEDICAL LLCNJT2026-04-01
00847627042194Caspase-3 (Cleaved)BIOCARE MEDICAL LLCNJT2026-04-01
00847627042590S100PBIOCARE MEDICAL LLCNJT2026-04-01
00847627042859CD33BIOCARE MEDICAL LLCNJT2026-04-01
07613336226568VENTANA® U6 DIG ProbeVentana Medical Systems, Inc.NJT2026-03-26
00847627041500Uroplakin II + Uroplakin IIIBIOCARE MEDICAL LLCNJT2025-11-19
00847627041845SOX11 (M)BIOCARE MEDICAL LLCNJT2025-11-19
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00847627042675CDX2 (RM)BIOCARE MEDICAL LLCNJT2025-11-19
00847627042736IgG4 (M)BIOCARE MEDICAL LLCNJT2025-11-19
00847627040640p53BIOCARE MEDICAL LLCNJT2025-11-10
00847627041975DOG1BIOCARE MEDICAL LLCNJT2025-11-10
00847627042811CD19 (RM) [RM332]BIOCARE MEDICAL LLCNJT2025-10-31
00847627041562Glutamine SynthetaseBIOCARE MEDICAL LLCNJT2025-10-23
00847627041609Cytokeratin 17 (CK17)BIOCARE MEDICAL LLCNJT2025-10-23
07613336234365VENTANA HER2 (CAL27) AssayVentana Medical Systems, Inc.NJT2025-10-21
00847627041821Lambda Light Chain [N10/2]BIOCARE MEDICAL LLCNJT2025-10-21
00847627041883Cytokeratin 5 (CK5)BIOCARE MEDICAL LLCNJT2025-10-21
07613336234433TRPS1 (SP532) Rabbit Monoclonal AntibodyVentana Medical Systems, Inc.NJT2025-10-16
00847627040008HMB45 + MART-1 + TyrosinaseBIOCARE MEDICAL LLCNJT2025-10-10
00847627040015HMB45 + MART-1 + TyrosinaseBIOCARE MEDICAL LLCNJT2025-10-10