FDA.reportPublic FDA data

Diagnostic BioSystems

Primary DI
00846405012244
Brand
Diagnostic BioSystems
Company
Diagnostic Biosystems, Inc.
Model
K037
Device description
10X Citrate Buffer pH 8.0, 500 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
JCCPh Buffer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCCPh BufferPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846405012244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846405012244008464050122448464050122440846405012244

GMDN Terms#

Term, Definition table
TermDefinition
Saline sodium citrate buffer IVDA salt-containing buffer intended to be used in hybridization assays to control the degree of stringency (homology between the probe and the filter bound nucleic acid) in the processing, staining, and/or testing of clinical specimens.

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
00846405000166Diagnostic BioSystemsMob5692026-06-09
00846405000173Diagnostic BioSystemsMob569-052026-06-09
00846405000180Diagnostic BioSystemsMob569-012026-06-09
00846405000678Diagnostic BioSystemsMob0802026-06-09
00846405000685Diagnostic BioSystemsMob080-052026-06-09
00846405000692Diagnostic BioSystemsMob080-012026-06-09
00846405000760Diagnostic BioSystemsMob0592026-06-09
00846405000777Diagnostic BioSystemsMob059-052026-06-09
00846405000784Diagnostic BioSystemsMob059-012026-06-09
00846405000791Diagnostic BioSystemsMob0542026-06-09
00846405000807Diagnostic BioSystemsMob054-052026-06-09
00846405000814Diagnostic BioSystemsMob054-012026-06-09
00846405001156Diagnostic BioSystemsMob2782026-06-09
00846405001163Diagnostic BioSystemsMob278-052026-06-09
00846405001170Diagnostic BioSystemsMob278-012026-06-09
00846405001187Diagnostic BioSystemsMob5532026-06-09
00846405001194Diagnostic BioSystemsMob553-012026-06-09
00846405001200Diagnostic BioSystemsMob553-052026-06-09
00846405001309Diagnostic BioSystemsMob2912026-06-09
00846405001316Diagnostic BioSystemsMob291-052026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405012442Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405014149Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405014156Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405016693Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405016709Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405016747Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405017355Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405022281Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405022298Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405022304Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405022311Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405022328Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405022335Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405023226Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405023936Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-08
00846405012268Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-05
00846405012275Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-05
00846405017379Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-05
00846405023301Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-05
00846405023370Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-05
00846405012213Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-04
00846405012220Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-04
00846405012237Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-04
00846405012251Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-04
00846405023288Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-04
00846405023295Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-04
04015630971008Antibody DiluentVentana Medical Systems, Inc.JCC2025-12-15
04015630972432ULTRA Cell Conditioning Solution (ULTRA CC1)Ventana Medical Systems, Inc.JCC2025-12-15
04015630985012ISH Probe DiluentVentana Medical Systems, Inc.JCC2025-12-15
00810170553585IHCSlmp, LLCJCC2025-03-31