FDA.reportPublic FDA data

Diagnostic BioSystems

Primary DI
00846405012237
Brand
Diagnostic BioSystems
Company
Diagnostic Biosystems, Inc.
Model
K036
Device description
10X Citrate Buffer pH 7.0, 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
00846405012237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846405012237008464050122378464050122370846405012237

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
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
00846405012213Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-04
00846405012220Diagnostic BioSystemsDiagnostic Biosystems, Inc.JCC2026-06-04
00846405012244Diagnostic 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
00810170553592IHCSlmp, LLCJCC2025-03-31
08435256719499TBS Tween 20 Buffer 10X q.s. 10LVITRO SAJCC2025-02-20
08435804515078TBS Tween 20 Buffer 10XVITRO SAJCC2025-02-20
00348783012699BufferProPREMIER DENTAL PRODUCTS COMPANYJCC2024-12-18
00860011780540Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
00860011780557Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
00860011780564Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
00860011780595Chemical Service Labs, LLCProtean Resources, LLC.JCC2024-03-18
07540207107803EasySep™ BufferStemcell Technologies Canada IncJCC2024-02-08
00380740136994AlinityAbbott Ireland DiagnosticsJCC2023-11-16
00860001977349OnsetOnpharma CompanyJCC2023-06-01
00810047421047N/AScientific Device Laboratory, Inc.JCC2023-01-31
00810047421054N/AScientific Device Laboratory, Inc.JCC2023-01-31
00847627014528PBS Plus 10XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014559Immunocare PBS 10XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014610TBSplus 10XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014627Automation Tween 20, 20XBIOCARE MEDICAL LLCJCC2022-12-07
00847627014634Immunocare TBS Wash Buffer 10XBIOCARE MEDICAL LLCJCC2022-12-07
0084762701466520% Tween 20BIOCARE MEDICAL LLCJCC2022-12-07
0084762701467220% Tween 20BIOCARE MEDICAL LLCJCC2022-12-07