FDA.reportPublic FDA data

Teco Diagnostics Triglyceride - GPO Liquid Reagent Set

Primary DI
10673486002256
Brand
Teco Diagnostics Triglyceride - GPO Liquid Reagent Set
Company
TECO DIAGNOSTICS
Model
T532-100
Catalog number
T532-100
Device description
Teco Diagnostics Triglyceride - GPO Liquid Reagent Set is used for the in vitro quantitative determination of Triglycerides in serum.
Published
2023-11-30
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
CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDTLipase Hydrolysis/Glycerol Kinase Enzyme, TriglyceridesClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486002256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600225610673486002256

GMDN Terms#

Term, Definition table
TermDefinition
Triglyceride 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 triglycerides 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
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10673486002287Teco Diagnostics Triglyceride - GPO Liquid Reagent SetTECO DIAGNOSTICSCDT2023-11-28
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