FDA.reportPublic FDA data

CL ELECTRODE, ISE MODULE

Primary DI
05999883586709
Brand
CL ELECTRODE, ISE MODULE
Company
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Model
Cl- Electrode
Catalog number
5203
Device description
Clinical Chemistry Test Systems / Chloride test system. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Published
2016-10-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGZElectrode, Ion-Specific, Chloride

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101741000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101741000DIATRON PICTUS 400Diatron Group2011-01-25CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15999883586706PackageGS11Not in Commercial Distribution
05999883586709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1599988358670615999883586706
05999883586709059998835867095999883586709

GMDN Terms#

Term, Definition table
TermDefinition
Chloride (Cl-) electrode IVDAn electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of chloride (Cl-) ions in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth40Millimeter
Height60Millimeter
Width90Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1207-450-4228John.Roche@diatron.com

Regulatory Flags#

DUNS number
427395277
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05999860094180Pictus 700 clinilcal chemistry analyzerPictus 700 clinilcal chemistry analyzer with ISEP700-32018-06-26
05999883586884Pictus 700 clinilcal chemistry analyzer Pictus 700 clinilcal chemistry analyzer W/out ISE P700-12018-06-26
05999883586891Pictus 400 Clinical chemistry analyzerPictus 400 clinical chemistry analyzer W/out ISE P400-12018-06-26
25999860094153Trigger Solutions Pack226491-TRP2026-01-05
159998600941705x TBS Wash BufferTWB562025-12-11
059998600941735x TBS Wash BufferTWB562025-12-11
05999860094227Pictus 400 Clinical chemistry analyzerPictus 400 clinical chemistry analyzer with barcodP400-32018-06-26
05999860094234Pictus 400 Clinical chemistry analyzerPictus 400 clinical chemistry analyzer with ISE anP400-42018-06-26
05999883586686NA ELECTRODE, ISE MODULENA+ Electrode52012016-10-06
05999883586693K ELECTRODE, ISE MODULEK+ Electrode52022016-10-06
05999883586419P780 Clinical Chemistry Analyzer with ISE moduleP780 Clinical Chemistry Analyzer with ISE moduleP780-12025-07-10
05999883586426P780 Clinical Chemistry AnalyzerP780 Clinical Chemistry AnalyzerP780-22025-07-10
05999883586907Atellica DT Cuvettes (280pcs)Atellica DT Cuvettes (280pcs)113105122025-06-13
15999883586751Atellica DT Solution 1 (S1)Atellica DT Solution 1 (S1)113105072025-04-30
15999883586867Atellica DT Solution 4 (S4)Atellica DT Solution 4 (S4)113105102025-04-30
45999883586752Atellica DT Solution 2 (S2)Atellica DT Solution 2 (S2)113105082025-04-30
05999883586747Atellica DT 250 Analyzer Atellica DT 250113105042025-04-30
15999883586744Atellica DT 250 Analyzer Atellica DT 250113105042025-04-30
25999883586758Atellica DT Solution 1 (S1)Atellica DT Solution 1 (S1)113105072025-04-30
15999883586850Atellica DT Solution 3 (S3)Atellica DT Solution 3 (S3)113105052025-04-30

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Primary DI, Brand, Company table
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00386100004385EasyRA Analyzer (ISE&LIS)MEDICA CORPORATIONCGZ2019-02-14
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00386100002503Na/K/Cl AnalyzerMEDICA CORPORATIONCGZ2018-12-11
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00386100002831ISE Reagent ModuleMEDICA CORPORATIONCGZ2018-12-11
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00386100002916Na/K/Cl/Li Solution Pack MEDICA CORPORATIONCGZ2018-12-04
00386100002923Na/K/Cl/Li Solution PackMEDICA CORPORATIONCGZ2018-12-04
00380740121686AlinityAbbott GmbHCGZ2018-05-30
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