FDA.reportPublic FDA data

LIPASE Color

Primary DI
00628063400782
Brand
LIPASE Color
Company
SEKISUI DIAGNOSTICS, LLC
Model
905-B
Catalog number
905-B
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
CHILIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHILipase-Esterase, Enzymatic, Photometric, LipaseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K897150000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K897150000LIPASE COLOR [TOYO] SERUM LIPASE TEST KITToyo Jozo Co., Ltd.1990-02-26CHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628063400782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628063400782006280634007826280634007820628063400782

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
966812344
Device count
1
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
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00380740204020ARCHITECTABBOTT IRELANDCHI2025-10-24
00380740204037AlinityABBOTT IRELANDCHI2025-10-24
06971674866916BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHI2023-07-22
06971674866923BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHI2023-07-22
06971674866930BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHI2023-07-22
06971674866947BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHI2023-07-22
06971674866954BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHI2023-07-22
06971674866961BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHI2023-07-22
06971674866978BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHI2023-07-22
05055273204247LIPASE (LPS)RANDOX LABORATORIES LIMITEDCHI2022-10-04
00817302024135CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT AU-621CAROLINA LIQUID CHEMISTRIES CORPORATIONCHI2022-08-19
00817302024357CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT CC621CAROLINA LIQUID CHEMISTRIES CORPORATIONCHI2022-08-19
00817302024470CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT DT621CAROLINA LIQUID CHEMISTRIES CORPORATIONCHI2022-08-19
00817302024616CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT ST621CAROLINA LIQUID CHEMISTRIES CORPORATIONCHI2022-08-19
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00630414292762Dimenison Vista Lipase Flex reagent cartridgeSiemens Healthcare Diagnostics Inc.CHI2021-11-05
00630414306254Dimenison Vista Lipase Flex reagent cartridgeSiemens Healthcare Diagnostics Inc.CHI2021-11-05
04015630926985Lipase colorimetric assayRoche Diagnostics GmbHCHI2021-02-08
04015630917570Lipase colorimetric assayRoche Diagnostics GmbHCHI2021-01-18
04015630934812Lipase colorimetricRoche Diagnostics GmbHCHI2021-01-18
00630414482446ADVIA® Chemistry LIP Lipase ReagentsSiemens Healthcare Diagnostics Inc.CHI2020-09-24
00630414596358Atellica CH LipSiemens Healthcare Diagnostics Inc.CHI2020-09-24
00842768020223Dimension Vista® Flex® reagent cartridge LIPLSiemens Healthcare Diagnostics Inc.CHI2020-09-24
00842768025532Dimension® Flex® reagent cartridge LIPLSiemens Healthcare Diagnostics Inc.CHI2020-09-24
03610230007105Yumizen C1200 LipaseHORIBA ABX SASCHI2020-08-28
10758750004683VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CHI2020-04-18
10758750009510VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CHI2020-04-18