FDA.reportPublic FDA data

Yumizen C1200 Amylase

Primary DI
03610230006849
Brand
Yumizen C1200 Amylase
Company
HORIBA ABX SAS
Model
1300023831
Published
2020-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JFJCatalytic Methods, Amylase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFJCatalytic Methods, AmylaseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070249000ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/HHoriba Abx2007-04-26CIC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03610230006849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610230006849036102300068493610230006849

GMDN Terms#

Term, Definition table
TermDefinition
Amylase isoenzyme IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple amylase isoenzymes in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
273647420
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03610230004883ABX PENTRA IMMUNO II CONTROL L/H12200016222016-08-23
03610230004623ABX CLEANER (0.5L)12109030112016-08-16
03610230009932ABX Micros 6013001465762026-01-23
03610230009444Yumizen H250013001021472024-11-29
03610230009451Yumizen H250013001021482024-11-29
03610230005774ABX PENTRA MICRO-ALB CAL12200019662016-09-05
03610230005781ABX PENTRA MICRO ALB CONTROL L/H12200019672016-08-16
03610230008232ABX Pentra Micro ALB 2 Cal13000325652017-07-07
03610230005187ABX PENTRA ALBUMIN CP12200016642016-08-23
03610230005767ABX PENTRA MICRO ALBUMIN CP12200019652016-08-16
03610230008225ABX Pentra Micro ALBUMIN 2 CP13000325632017-06-27
03610230007235Yumizen C1200 Albumin U/CSF13000238712020-09-14
03610230007464Yumizen C1200 Micro Alb U/CSF Cal Normal 1300023894 2020-09-07
03610230007891Yumizen C1200 U/CSF L1 Micro Alb Control 1300023948 2020-09-07
03610230007914Yumizen C1200 U/CSF L2 Micro Alb Control 1300023949 2020-09-07
03610230006825Yumizen C1200 Albumin13000237992020-05-06
03610230008966Yumizen P800013000333272025-07-07
03610230009611ABX Minocal530010030053001003002024-09-27
03610230008584BFTROL13000394052024-09-26
03610230009581ABX Minotrol 16530010031253001003122024-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740155612AlinityABBOTT IRELANDJFJ2025-12-19
00380740156718ARCHITECTABBOTT IRELANDJFJ2025-12-19
10673486001129α – AMYLASE LIQUID REAGENT (KINETIC METHOD)TECO DIAGNOSTICSJFJ2023-07-20
10673486001136α – AMYLASE LIQUID REAGENT (KINETIC METHOD) TC MATRIX-240/480TECO DIAGNOSTICSJFJ2023-07-20
10673486001143AMYLASE REAGENT SET (KINETIC METHOD)TECO DIAGNOSTICSJFJ2023-07-20
07613336121009a-Amylase EPS ver.2Roche Diagnostics GmbHJFJ2020-03-05
07613336121016a-Amylase EPS PancreaticRoche Diagnostics GmbHJFJ2020-03-05
00380740161668ARCHITECTAbbott GmbHJFJ2019-11-15
00630414238357Atellica CH AMY_2Siemens Healthcare Diagnostics Inc.JFJ2019-09-03
00386100002138AMY Reagent KitMEDICA CORPORATIONJFJ2019-02-14
00380740135461AlinityAbbott GmbHJFJ2018-10-05
00628063401062Amylase AssaySEKISUI DIAGNOSTICS, LLCJFJ2018-08-09
00817274022771JAS DiagnosticsDREW SCIENTIFIC, INC.JFJ2018-07-19
00630414595641Atellica CH PAmySiemens Healthcare Diagnostics Inc.JFJ2017-12-21
05060500091705Synermed®INFRARED LABORATORY SYSTEMS LLCJFJ2017-02-28
00817274022320JAS DiagnosticsDREW SCIENTIFIC, INC.JFJ2016-10-19
00817302022964CAROLINA LIQUID CHEMISTRIES CORP.® AMY REAGENT PRODUCT NO. DT227CAROLINA LIQUID CHEMISTRIES CORPORATIONJFJ2016-10-17
00817274022849JAS DiagnosticsDREW SCIENTIFIC, INC.JFJ2016-10-11
00842768005404Dimension® Flex® reagent cartridge AMYSiemens Healthcare Diagnostics Inc.JFJ2016-09-24
00842768015069Dimension Vista® Flex® reagent cartridge AMYSiemens Healthcare Diagnostics Inc.JFJ2016-09-24
00630414510156ADVIA® Chemistry PAMY Pancreatic Amylase ReagentsSiemens Healthcare Diagnostics Inc.JFJ2016-09-24
00657498000489a-Amylase LiquiColor®STANBIO LABORATORY, L.P.JFJ2016-09-23
00657498001707Sirrus® Alpha-Amylase LiquiColor®STANBIO LABORATORY, L.P.JFJ2016-09-23
04015630918935Amylase EPS ver2Roche Diagnostics GmbHJFJ2016-09-20
04015630913893AMYP Amylase EPS PancreaticRoche Diagnostics GmbHJFJ2016-09-20
04015630924875alpha-Amylase EPS ver.2Roche Diagnostics GmbHJFJ2016-09-20
04015630924882alpha-Amylase EPS PancreaticRoche Diagnostics GmbHJFJ2016-09-20
04015630926848alpha-Amylase EPS PancreaticRoche Diagnostics GmbHJFJ2016-09-20
04015630926886alpha-Amylase EPS ver.2Roche Diagnostics GmbHJFJ2016-09-20
05060500090128Synermed®INFRARED LABORATORY SYSTEMS LLCJFJ2016-09-20