FDA.reportPublic FDA data

Diagnostic BioSystems

Primary DI
00846405000333
Brand
Diagnostic BioSystems
Company
Diagnostic Biosystems, Inc.
Model
Mob460-01
Device description
CD163, Clone 10D6, 0.1 ml
Published
2026-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00846405000333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846405000333008464050003338464050003330846405000333

GMDN Terms#

Term, Definition table
TermDefinition
CD163 cell marker 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 CD163 cell marker in a clinical specimen.

Regulatory Flags#

DUNS number
926549064
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
00846405000036Diagnostic BioSystemsMob429-012026-06-08
00846405000227Diagnostic BioSystemsMob125R2026-06-08
00846405000234Diagnostic BioSystemsMob125-05R2026-06-08
00846405000241Diagnostic BioSystemsMob125R-012026-06-08
00846405000319Diagnostic BioSystemsMob4602026-06-08
00846405000326Diagnostic BioSystemsMob460-052026-06-08
00846405000371Diagnostic BioSystemsMob1172026-06-08
00846405000388Diagnostic BioSystemsMob117-052026-06-08
00846405000395Diagnostic BioSystemsMob117-012026-06-08
00846405000463Diagnostic BioSystemsMob2942026-06-08
00846405000470Diagnostic BioSystemsMob294-052026-06-08
00846405000487Diagnostic BioSystemsMob294-012026-06-08
00846405000524Diagnostic BioSystemsMob0282026-06-08
00846405000531Diagnostic BioSystemsMob028-052026-06-08
00846405000548Diagnostic BioSystemsMob028-012026-06-08
00846405000616Diagnostic BioSystemsMob3322026-06-08
00846405000623Diagnostic BioSystemsMob332-052026-06-08
00846405000630Diagnostic BioSystemsMob332-012026-06-08
00846405000913Diagnostic BioSystemsMob3092026-06-08
00846405000920Diagnostic BioSystemsMob309-052026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405000036Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000227Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000234Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000241Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000319Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000326Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000371Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000388Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000395Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000463Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000470Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000487Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000524Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000531Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000548Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000616Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000623Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000630Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000913Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000920Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000937Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000975Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000982Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405000999Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405001002Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405001019Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405001026Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405001279Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405001286Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08
00846405001293Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-08