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
00846405016808Diagnostic BioSystemsC0062026-07-09
00846405016822Diagnostic BioSystemsC0042026-07-09
00846405016839Diagnostic BioSystemsC0052026-07-09
00846405016846Diagnostic BioSystemsC0022026-07-09
00846405020102Diagnostic BioSystemsC002-NI2026-07-09
00846405020119Diagnostic BioSystemsC004-NI2026-07-09
00846405020126Diagnostic BioSystemsC005-NI2026-07-09
00846405020133Diagnostic BioSystemsC006-NI2026-07-09
00846405000166Diagnostic BioSystemsMob5692026-06-09
00846405000173Diagnostic BioSystemsMob569-052026-06-09
00846405000180Diagnostic BioSystemsMob569-012026-06-09
00846405000678Diagnostic BioSystemsMob0802026-06-09
00846405000685Diagnostic BioSystemsMob080-052026-06-09
00846405000692Diagnostic BioSystemsMob080-012026-06-09
00846405000760Diagnostic BioSystemsMob0592026-06-09
00846405000777Diagnostic BioSystemsMob059-052026-06-09
00846405000784Diagnostic BioSystemsMob059-012026-06-09
00846405000791Diagnostic BioSystemsMob0542026-06-09
00846405000807Diagnostic BioSystemsMob054-052026-06-09
00846405000814Diagnostic BioSystemsMob054-012026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405016808Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405016822Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405016839Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405016846Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020102Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020119Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020126Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
00846405020133Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-07-09
05055331330581BOND-PRIMELEICA BIOSYSTEMS NEWCASTLE LTDNJT2026-07-08
00846405000166Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000173Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000180Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000678Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000685Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000692Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000760Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000777Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000784Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000791Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000807Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000814Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001156Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001163Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001170Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001187Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001194Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001200Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001309Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001316Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001323Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09