FDA.reportPublic FDA data

Diagnostic BioSystems

Primary DI
00846405012282
Brand
Diagnostic BioSystems
Company
Diagnostic Biosystems, Inc.
Model
K011
Device description
Alk. Phos. Enhancer, 250 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
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846405012282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846405012282008464050122828464050122820846405012282

GMDN Terms#

Term, Definition table
TermDefinition
Alkaline phosphatase (ALP) isoenzyme 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 one or multiple alkaline phosphatase (ALP) isoenzymes 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
00846405000210Diagnostic BioSystemsMob440-012026-06-05
00846405000258Diagnostic BioSystemsMob5582026-06-05
00846405000265Diagnostic BioSystemsMob558-012026-06-05
00846405000272Diagnostic BioSystemsMob558-052026-06-05
00846405000289Diagnostic BioSystemsMob1302026-06-05
00846405000296Diagnostic BioSystemsMob130-052026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405012299Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012367Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012374Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012381Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012398Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012404Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405012480Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014095Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014132Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014217Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405014224Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405016716Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017065Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017072Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017089Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017331Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405017362Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405019298Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023233Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023257Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023264Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023318Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023325Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405023974Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405024421Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-05
00846405020331Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-04-30
10845357044409Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.PPM2026-04-15
08435804523417Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07
08435804524551Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07
05407010128222Bulk Packaged ster. filtered WFI - 500mlLonza VerviersPPM2026-03-30