FDA.reportPublic FDA data

Diagnostic BioSystems

Primary DI
00846405000210
Brand
Diagnostic BioSystems
Company
Diagnostic Biosystems, Inc.
Model
Mob440-01
Device description
PSMA, Clone 3E6, 0.1 ml
Published
2026-06-05
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
00846405000210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846405000210008464050002108464050002100846405000210

GMDN Terms#

Term, Definition table
TermDefinition
Prostate-specific membrane antigen (PSMA) 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 prostate-specific membrane antigen (PSMA), also known as glutamate carboxypeptidase 2, in a clinical specimen.

Regulatory Flags#

DUNS number
926549064
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
00846405000043Diagnostic BioSystemsMob3192026-06-05
00846405000050Diagnostic BioSystemsMob319-052026-06-05
00846405000067Diagnostic BioSystemsMob319-012026-06-05
00846405000074Diagnostic BioSystemsMob2672026-06-05
00846405000081Diagnostic BioSystemsMob267-052026-06-05
00846405000098Diagnostic BioSystemsMob267-012026-06-05
00846405000104Diagnostic BioSystemsMob0052026-06-05
00846405000111Diagnostic BioSystemsMob005-052026-06-05
00846405000128Diagnostic BioSystemsMob005-012026-06-05
00846405000135Diagnostic BioSystemsMob4422026-06-05
00846405000142Diagnostic BioSystemsMob442-052026-06-05
00846405000159Diagnostic BioSystemsMob442-012026-06-05
00846405000197Diagnostic BioSystemsMob4402026-06-05
00846405000203Diagnostic BioSystemsMob440-052026-06-05
00846405000258Diagnostic BioSystemsMob5582026-06-05
00846405000265Diagnostic BioSystemsMob558-012026-06-05
00846405000272Diagnostic BioSystemsMob558-052026-06-05
00846405000289Diagnostic BioSystemsMob1302026-06-05
00846405000296Diagnostic BioSystemsMob130-052026-06-05
00846405000302Diagnostic BioSystemsMob130-012026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405000739Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-07
00846405000746Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-07
00846405000753Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-07
00846405001514Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-07
00846405001521Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-07
00846405001538Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-07
00846405001576Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-07
00846405001583Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-07
00846405001590Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-07
00846405002566Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-07
00846405002573Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-07
00846405002580Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-07
00846405000494Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-06
00846405000500Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-06
00846405000517Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-06
00846405000852Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-06
00846405000869Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-06
00846405000876Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-06
00846405001729Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-06
00846405001736Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-06
00846405001743Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-06
00846405001996Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-06
00846405002009Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-06
00846405002016Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-06
00846405003945Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-06
00846405003952Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-06
00846405003969Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-06
00846405000043Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-05
00846405000050Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-05
00846405000067Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-05