FDA.reportPublic FDA data

TRIGLYCERIDE

Primary DI
00628063400911
Brand
TRIGLYCERIDE
Company
Sekisui Diagnostics, LLC
Model
SK236-10
Catalog number
SK236-10
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00628063400911PrimaryGS10
10628063400918Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628063400911006280634009116280634009110628063400911
1062806340091810628063400918

GMDN Terms#

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

Regulatory Flags#

DUNS number
966812344
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00742860000027OSOM COVID-19 Antigen Rapid Test1066-401066-402024-12-16
00742860000034OSOM COVID-19 Antigen Control Kit106810682024-12-16
00742860000041OSOM COVID-19 Antigen Home Test1067-401067-402024-12-16
00742860000072OSOM Flu SARS-CoV-2 Combo Control Kit10792024-12-16
00742860000089OSOM Flu SARS-CoV-2 Combo Home107410742024-12-16
00742860100055OSOM BV Blue 25T Kit1831832025-12-29
00742860100314OSOM Vaginal Transport Swab Set1851852018-04-05
00742860100390OSOM ULTRA PLUS FLU A&B Test10322020-06-01
00742860100406OSOM ULTRA PLUS FLU A&B Control Kit10342020-06-01
00742860100673OSOM COVID-19 Test109210922026-01-19
00742860100680OSOM BVBlue Transport Swabs1862026-02-23
00742860100062OSOM BV Blue Control Kit1841842025-12-29
00742860000065OSOM Flu SARS-CoV-2 Combo Test10802024-12-16
00628063401291Acetaminophen03R74202023-05-08
00628063401307Acetaminophen Calibrator03R74012023-05-08
00628063401314Alinity c Acetaminophen07P54202023-05-08
00628063401321Alinity c Acetaminophen Calibrator07P54012023-05-08
00628063401222DC-TROL LEVELS 1 & 2SM-0572020-03-30
00628063401116MicroalbuminSK252-20SK252-202019-10-02
00628063401185Acetaminophen AssaySK507-50SK507-502019-10-02

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
06971674860228BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860266BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860280BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860303BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860310BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860327BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860334BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860341BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860358BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860365BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860372BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860389BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674868088BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860204BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860211BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860235BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860242BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860259BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860273BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860297BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
05055273209549TRIGLYCERIDES (TRIGS)RANDOX LABORATORIES LIMITEDCDT2022-10-05
00817302024180CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDE REAGENT KIT BL213CAROLINA LIQUID CHEMISTRIES CORPORATIONCDT2022-08-19
00817302024265CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDES REAGENT KIT CC213CAROLINA LIQUID CHEMISTRIES CORPORATIONCDT2022-08-19