FDA.reportPublic FDA data

Diagnostic BioSystems

Primary DI
00846405012541
Brand
Diagnostic BioSystems
Company
Diagnostic Biosystems, Inc.
Model
K009
Device description
Solution Pepsin, 50 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
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846405012541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846405012541008464050125418464050125410846405012541

GMDN Terms#

Term, Definition table
TermDefinition
Pepsin IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of pepsin 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
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
00846405000333Diagnostic BioSystemsMob460-012026-06-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405012305Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012312Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012329Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012411Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012428Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012435Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012459Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012466Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012473Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012497Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012503Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012510Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012527Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012534Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012558Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012565Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012589Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405013432Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405014163Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405014170Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405014200Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405016730Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405016778Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405017133Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405017140Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023219Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023271Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023356Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023363Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023387Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08