FDA.reportPublic FDA data

Amylase Assay

Primary DI
00628063401062
Brand
Amylase Assay
Company
SEKISUI DIAGNOSTICS, LLC
Model
SK5383-40
Catalog number
SK5383-40
Published
2018-08-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JFJCATALYTIC METHODS, AMYLASE

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628063401062PrimaryGS10
10628063401069Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628063401062006280634010626280634010620628063401062
1062806340106910628063401069

GMDN Terms#

Term, Definition table
TermDefinition
Total amylase IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total amylase 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

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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
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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07613336121016a-Amylase EPS PancreaticRoche Diagnostics GmbHJFJ2020-03-05
00380740161668ARCHITECTAbbott GmbHJFJ2019-11-15
00630414238357Atellica CH AMY_2Siemens Healthcare Diagnostics Inc.JFJ2019-09-03
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00380740135461AlinityAbbott GmbHJFJ2018-10-05
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
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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
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