FDA.reportPublic FDA data

Teco Diagnostics Direct HDL Cholesterol Reagent Set

Primary DI
10673486001891
Brand
Teco Diagnostics Direct HDL Cholesterol Reagent Set
Company
TECO DIAGNOSTICS
Model
H513-100
Catalog number
H513-100
Device description
Teco Diagnostics Direct HDL Cholesterol Reagent Set is used for the quantitative determination of high-density lipoprotein (HDL) in human serum or plasma on an automated analyzer. For in vitro diagnostic use only.
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
LBRLdl & Vldl Precipitation, Hdl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBRLdl & Vldl Precipitation, HdlClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050823000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050823000DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATORTeco Diagnostics2005-07-26LBR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486001891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600189110673486001891

GMDN Terms#

Term, Definition table
TermDefinition
High density lipoprotein (HDL) cholesterol 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 high density lipoprotein (HDL) cholesterol lipid 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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Primary DI, Brand, Company table
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