FDA.reportPublic FDA data

Diagnostic BioSystems

Primary DI
00846405000029
Brand
Diagnostic BioSystems
Company
Diagnostic Biosystems, Inc.
Model
Mob429-05
Device description
MSH6, Clone 44, 0.5 ml
Published
2026-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
00846405000029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846405000029008464050000298464050000290846405000029

GMDN Terms#

Term, Definition table
TermDefinition
MSH6 antigen 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 MSH6 antigen in a clinical specimen.

Regulatory Flags#

DUNS number
926549064
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
00846405000005Diagnostic BioSystemsPDM572-252026-05-01
00846405000012Diagnostic BioSystemsMob4292026-05-01
00846405020331Diagnostic BioSystems07342098001K0022026-04-30

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Primary DI, Brand, Company table
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07613336234365VENTANA HER2 (CAL27) AssayVentana Medical Systems, Inc.NJT2025-10-21
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