FDA.reportPublic FDA data

Teco Diagnostics Glucose (Oxidase) Liquid Reagent Set for TC Matrix

Primary DI
10673486001761
Brand
Teco Diagnostics Glucose (Oxidase) Liquid Reagent Set for TC Matrix
Company
TECO DIAGNOSTICS
Model
G520-940TM
Catalog number
G520-940TM
Device description
Teco Diagnostics Glucose (Oxidase) Liquid Reagent Set for TC Matrix is used for the quantitative determination of total glucose in human serum on TC Matrix analyzers.
Published
2023-11-10
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
CGAGlucose Oxidase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914159000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914159000GLUCOSE REAGENT SETTech Intl. Co.1992-01-27CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486001761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600176110673486001761

GMDN Terms#

Term, Definition table
TermDefinition
Glucose 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 glucose in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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

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10673486002478GLUCOPAD TC-SMART+ Lancets KitG852-E-001G852-E-0012025-06-10
10673486002461GLUCOPAD TC-SMART+ Lancets KitG852-E-001G852-E-0012025-05-14
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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