FDA.reportPublic FDA data

Synchron

Primary DI
15099590202491
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
A28937
Catalog number
A28937
Device description
SYNCHRON Systems ISE Electrolyte Reference
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
15099590202491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959020249115099590202491

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologiesA collection of reagents and other associated materials intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample, using multiple technologies such as ion-selective electrode (ISE) and haemoximetry in a single analyser. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16
15099590806422ACCESS anti-HAV CALIBRATORD258322026-01-16
15099590806439ACCESS anti-HAV QCD258332026-01-16
15099590799717MicroScanV5.03D238242025-12-17
15099590799724MicroScanV5.03D238252025-12-17
15099590799755MicroScanV5.03D238282025-12-17
15099590799762MicroScanV5.03D238292025-12-17
05099590798973MicroScanD18443D184432025-12-08
05099590798980MicroScanD18444D184442025-12-08
05099590798997MicroScanD184452025-12-08
05099590799000MicroScanD184462025-12-08
05099590799017MicroScanD184472025-12-08
05099590799024MicroScanD184482025-12-08
15099590799243MicroScanV5.03 PU11ED233522025-12-08
15099590799250MicroScanV5.03 PU11D233542025-12-08
15099590807146MicroScanV5.03 DD07ED336042025-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033891322595CHORUS NEGATIVE CONTROL/SAMPLE DILUENTDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
08033891322816CHORUS EVO DECONTAMINATION BUFFERDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
08033891322823CHORUS EVO SANITIZING SOLUTIONDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
08033891328849CHORUS SANITIZING SOLUTIONDIESSE DIAGNOSTICA SENESE SPAPPM2026-03-23
00847627043726NeoPath Background Punisher BIOCARE MEDICAL LLCPPM2026-03-11
04049016151302FITC-labelled anti-human IgA with Evans BlueEUROIMMUN Medizinische Labordiagnostika AGPPM2026-03-04
04049016151319FITC-labelled anti-human IgG with Evans BlueEUROIMMUN Medizinische Labordiagnostika AGPPM2026-02-10
04049016151647FITC-labelled anti-human IgG with Evans BlueEUROIMMUN Medizinische Labordiagnostika AGPPM2026-02-10
00630414312460Atellica HEMA CleanerSiemens Healthcare Diagnostics Inc.PPM2026-02-06
00630414312507Atellica HEMA DeconSiemens Healthcare Diagnostics Inc.PPM2026-02-06
05407010129847Buffer C_SUO-001_Module L : 1000L BagLonza VerviersPPM2026-02-05
05407010129854Buffer C_SUO-001_Module L : 1L Bag SampLonza VerviersPPM2026-02-05
00847627043023NeoPATH Pro Rabbit Amp AP Plus KitBIOCARE MEDICAL LLCPPM2026-01-29
00847627043047NeoPATH Pro Universal AP Plus Polymer KitBIOCARE MEDICAL LLCPPM2026-01-29
00847627043061NeoPATH Pro Antigen Retrieval 1 (AR1)BIOCARE MEDICAL LLCPPM2026-01-29
04049016151340FITC-labelled anti-human IgG with propidium iodide for EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPPM2026-01-29
04049016151654FITC-labelled anti-human IgG with propidium iodide for EUROPatternEUROIMMUN Medizinische Labordiagnostika AGPPM2026-01-29
05430003908471SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908693SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908631SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908709SEEKER®Lacar MDX TechnologiesPPM2026-01-15
05430003908730LaCARLacar MDX TechnologiesPPM2026-01-15
05430003908785LaCAR Lacar MDX TechnologiesPPM2026-01-15
05430003908808LaCARLacar MDX TechnologiesPPM2026-01-15
05430003908846LaCAR Lacar MDX TechnologiesPPM2026-01-15
05430003908860LaCAR Lacar MDX TechnologiesPPM2026-01-15
08435804522199FISH PT KITVITRO SAPPM2026-01-15
08435804522212DEWAX-2 FISHVITRO SAPPM2026-01-15
08435804522366FISH PT KITVITRO SAPPM2026-01-15
08435804522397DEWAX-2 FISH VITRO SAPPM2026-01-15