FDA.reportPublic FDA data

Teco Diagnostics Potassium Reagent TC-Matrix

Primary DI
10673486002157
Brand
Teco Diagnostics Potassium Reagent TC-Matrix
Company
TECO DIAGNOSTICS
Model
P605-510TM
Catalog number
P605-510TM
Device description
Teco Diagnostics Potassium Reagent TC-Matrix is used for the colorimetric determination of potassium in human serum and plasma on TC-Matrix analyzers.
Published
2023-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CEJTetraphenyl Borate, Colorimetry, Potassium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEJTetraphenyl Borate, Colorimetry, PotassiumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K902574000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902574000POTASSIUM REAGENT SETTech-Co, Inc.1990-07-10CEJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486002157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600215710673486002157

GMDN Terms#

Term, Definition table
TermDefinition
Potassium (K+) 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 potassium (K+) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7144631111hello@tecodiagnostics.com

Regulatory Flags#

DUNS number
185067774
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10673486014037Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-240C514-650TC2C514-650TC22026-04-30
10673486014044Teco Diagnostics Creatinine (Kinetic) Reagent Kit for TC-Matrix-480C514-650TC4C514-650TC42026-04-30
10673486014020Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Dipstick TestP597-25P597-252026-04-09
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10673486013993Teco Diagnostics Rapid Fecal Occult Blood (FOB) TestF735-25F735-252026-01-30
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10673486002478GLUCOPAD TC-SMART+ Lancets KitG852-E-001G852-E-0012025-06-10
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10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-MatrixTC-Matrix2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-MATRIX-160TC-MATRIX-1602025-05-28
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10673486000726Teco Diagnostics Glucopad Blood Glucose Test StripsGlucopad Blood Glucose Test StripsG852-B-0022024-12-19
10673486002454Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestP596-25P596-252024-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10673486002133Teco Diagnostics Potassium Reagent SetTECO DIAGNOSTICSCEJ2023-07-28
05055273204933Potassium (K)RANDOX LABORATORIES LIMITEDCEJ2016-09-24
05055273204940Potassium (K)RANDOX LABORATORIES LIMITEDCEJ2016-09-24