FDA.reportPublic FDA data

GENCHEM™ Amylase Reagent

Primary DI
00851445007044
Brand
GENCHEM™ Amylase Reagent
Company
GENCHEM INC
Model
GEN-AMY
Catalog number
GEN-AMY
Device description
10/17/2022
Published
2016-09-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K932888000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932888000INTERSECT SYSTEMS DIRECT AMYLASE REAGENTIntersect Systems, Inc.1994-01-31JFJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851445007044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851445007044008514450070448514450070440851445007044

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

Contacts#

Phone, Email table
PhoneEmail
+1(714)529-7125lorlow@genchem.org

Regulatory Flags#

DUNS number
193856866
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851445007006GENCHEM™ Albumin ReagentGEN-ALBGEN-ALB2016-09-19
00851445007013GENCHEM™ Albumin ReagentGEN-ALB-GGEN-ALB-G2016-09-19
00851445007020GENCHEM™ Alkaline PhosphataseGEN-ALP R1GEN-ALP R12016-09-19
00851445007037GENCHEM™ Alkaline PhosphataseGEN-ALP R2GEN-ALP R22016-09-19
00851445007099GENCHEM™Calcium, Azo Dye ReagentGEN-CA3GEN-CA32016-09-19
00851445007211GENCHEM™ Glucose Oxidase ReagentGEN-GLU3GEN-GLU32016-09-19
00851445007228GENCHEM™ Glucose Oxidase ReagentGEN-GLU LXGEN-GLU LX2016-09-19
00851445007235GENCHEM™ Glucose ReagentGEN-GLU4GEN-GLU42016-09-19
00851445007051GENCHEM™ AST/SGOTGEN-AST R1GEN-AST R12016-09-19
00851445007068GENCHEM™Electrode, Ion Specific, Urea Nitrogen (BUN) reagentGEN-BUN LXGEN-BUN LX2016-09-19
00851445007075GENCHEM™ Electrode, Ion Specific, Urea Nitrogen (BUN) reagentGEN-BUN3GEN-BUN32016-09-19
00851445007082GENCHEM™ UREAGEN-BUN R1GEN-BUN R12016-09-19
00851445007105GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 1GEN-CAL 1GEN-CAL 12016-09-19
00851445007112GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 2GEN-CAL 2GEN-CAL 22016-09-19
00851445007129GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 3GEN-CAL 3GEN-CAL 32016-09-19
00851445007136GENCHEM™ CK-NAC ReagentGEN-CK R1GEN-CK R12016-09-19
00851445007143GENCHEM™ CK-NAC ReagentGEN-CK R2GEN-CK R22016-09-19
00851445007150GENCHEM™ CO2 Acid ReagentGEN-CO2ACIDGEN-CO2ACID2016-09-19
00851445007167GENCHEM™ CO2 Acid ReagentGEN-CO2ALKGEN-CO2ALK2016-09-19
00851445007174GENCHEM™ Creatinine Test ReagentGEN-CREA R1(Base)GEN-CREA R1(Base)2016-09-19

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
03610230006849Yumizen C1200 AmylaseHORIBA ABX SASJFJ2020-08-31
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