FDA.reportPublic FDA data

Diagnostic BioSystems

Primary DI
00846405013722
Brand
Diagnostic BioSystems
Company
Diagnostic Biosystems, Inc.
Model
PDM572-10MM
Device description
PD-L1, Clone 405-9A11, 10 ml
Published
2026-06-04
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
00846405013722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846405013722008464050137228464050137220846405013722

GMDN Terms#

Term, Definition table
TermDefinition
Programmed death-ligand 1 (PD-L1) 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 programmed death-ligand 1 (PD-L1), also known as CD274, 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
00846405000432Diagnostic BioSystemsMob0012026-06-04
00846405000449Diagnostic BioSystemsMob001-052026-06-04
00846405001422Diagnostic BioSystemsMob1282026-06-04
00846405001439Diagnostic BioSystemsMob128-052026-06-04
00846405001446Diagnostic BioSystemsMob128-012026-06-04
00846405002115Diagnostic BioSystemsMob0322026-06-04
00846405002122Diagnostic BioSystemsMob032-052026-06-04
00846405002139Diagnostic BioSystemsMob032-012026-06-04
00846405003587Diagnostic BioSystemsMob0022026-06-04
00846405003594Diagnostic BioSystemsMob002-052026-06-04
00846405003600Diagnostic BioSystemsMob002-012026-06-04
00846405003853Diagnostic BioSystemsMob2342026-06-04
00846405003860Diagnostic BioSystemsMob234-052026-06-04
00846405003877Diagnostic BioSystemsMob234-012026-06-04
00846405005789Diagnostic BioSystemsPDM003-252026-06-04
00846405005796Diagnostic BioSystemsPDM0032026-06-04
00846405006045Diagnostic BioSystemsPDM0992026-06-04
00846405006809Diagnostic BioSystemsPDM0022026-06-04
00846405007325Diagnostic BioSystemsPDM1652026-06-04
00846405007486Diagnostic BioSystemsPDR0022026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405000432Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405000449Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405001422Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405001439Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405001446Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405002115Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405002122Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405002139Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405003587Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405003594Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405003600Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405003853Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405003860Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405003877Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405005789Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405005796Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405006045Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405006809Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405007325Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405007486Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405009503Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405009510Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405010240Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405012060Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405012077Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405012084Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405013708Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405013715Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405013746Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04
00846405013753Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-04