FDA.reportPublic FDA data

Teco Diagnostics Sodium Reagent Set

Primary DI
10673486002188
Brand
Teco Diagnostics Sodium Reagent Set
Company
TECO DIAGNOSTICS
Model
S600-50
Catalog number
S600-50
Device description
Teco Diagnostics Sodium Reagent Set is used for the colorimetric determination of sodium in human serum and plasma.
Published
2023-11-14
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
CEIUranyl Acetate/Zinc Acetate, Sodium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEIUranyl Acetate/Zinc Acetate, SodiumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K902572000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902572000SODIUM REAGENT SETTech Intl. Co.1990-07-10CEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486002188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600218810673486002188

GMDN Terms#

Term, Definition table
TermDefinition
Sodium (Na+) 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 sodium (Na+) 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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10673486014013Teco Diagnostics Chemistry CalibratorTC-CAL-MULTITC-CAL-MULTI2026-03-20
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10673486013993Teco Diagnostics Rapid Fecal Occult Blood (FOB) TestF735-25F735-252026-01-30
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10673486001013Albumin Reagent SetA502-480A502-4802023-07-07
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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
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-Matrix-240TC-Matrix-2402025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTC-Matrix-480TC-Matrix-4802025-05-28
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
00657498000984Potassium TestSTANBIO LABORATORY, L.P.CEI2016-09-24
05055273204698NaRANDOX LABORATORIES LIMITEDCEI2016-09-16
05055273204704NaRANDOX LABORATORIES LIMITEDCEI2016-09-16
05055273209310NaRANDOX LABORATORIES LIMITEDCEI2016-09-16