FDA.reportPublic FDA data

TRIGLYCERIDE-SL

Primary DI
00628063400898
Brand
TRIGLYCERIDE-SL
Company
SEKISUI DIAGNOSTICS, LLC
Model
236-60
Catalog number
236-60
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961281000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961281000TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60Diagnostic Chemicals , Ltd.1996-08-16CDT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628063400898PrimaryGS10
10628063400895Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628063400898006280634008986280634008980628063400898
1062806340089510628063400895

GMDN Terms#

Term, Definition table
TermDefinition
Triglyceride IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of triglycerides in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
966812344
Device count
2
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00742860100413Acucy Printer Paper10192026-02-27
10742860100410Acucy Printer Paper10192026-02-27
00742860100444Acucy Reader A/C Adapter10432026-02-27
00742860100475Acucy System Universal Drawer10512026-02-27
00742860100680OSOM BVBlue Transport Swabs1862026-02-23
50742860100685OSOM BVBlue Transport Swabs1862026-02-23
00742860100338Acucy System10392019-09-24
00742860100673OSOM COVID-19 Test109210922026-01-19
10742860100670OSOM COVID-19 Test109210922026-01-19
00742860100055OSOM BV Blue 25T Kit1831832025-12-29
10742860100052OSOM BV Blue 25T Kit1831832025-12-29
00742860100062OSOM BV Blue Control Kit1841842025-12-29
00742860100666OSOM RSV Test Home109110912025-05-19
00742860000065OSOM Flu SARS-CoV-2 Combo Test10802024-12-16
00628063400058ALBUMIN Assay200-05200-052016-09-16
00628063400065ALBUMIN Assay200-45200-452016-09-16
00628063400072ALBUMINSK200-10SK200-102016-09-20
10742860100663OSOM RSV Test Home109110912025-05-19
00742860000027OSOM COVID-19 Antigen Rapid Test1066-401066-402024-12-16
00742860000034OSOM COVID-19 Antigen Control Kit106810682024-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850053916151IDG/SanzayIDG/SANZAY CorporationCDT2024-01-12
10673486002256Teco Diagnostics Triglyceride - GPO Liquid Reagent SetTECO DIAGNOSTICSCDT2023-11-30
10673486002270Teco Diagnostics Triglyceride - GPO Liquid Reagent SetTECO DIAGNOSTICSCDT2023-11-28
10673486002287Teco Diagnostics Triglyceride - GPO Liquid Reagent SetTECO DIAGNOSTICSCDT2023-11-28
10673486002294Teco Diagnostics Triglyceride Reagent Kit TC-MatrixTECO DIAGNOSTICSCDT2023-11-28
10673486002225Teco Diagnostics Triglyceride -GPO Reagent SetTECO DIAGNOSTICSCDT2023-11-14
10673486002232Teco Diagnostics Triglyceride -GPO Reagent SetTECO DIAGNOSTICSCDT2023-11-14
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06971674860327BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
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06971674860242BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860259BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
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