FDA.reportPublic FDA data

Teco Diagnostics Lipase Reagent Set

Primary DI
10673486002089
Brand
Teco Diagnostics Lipase Reagent Set
Company
TECO DIAGNOSTICS
Model
L537-100
Catalog number
L537-100
Device description
Teco Diagnostics Lipase Reagent Set is used for the quantitative turbidimetric determination of pancreatic lipase in human serum.
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
CETOlive Oil Emulsion (Turbidimetric), Lipase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CETOlive Oil Emulsion (Turbidimetric), LipaseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K915706000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K915706000LIPASE REAGENT SETTech Intl. Co.1992-02-18CET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10673486002089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1067348600208910673486002089

GMDN Terms#

Term, Definition table
TermDefinition
Lipase 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 lipase 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

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