FDA.reportPublic FDA data

AMY Reagent Kit

Primary DI
00386100002138
Brand
AMY Reagent Kit
Company
MEDICA CORPORATION
Model
10217-4
Catalog number
10217-4
Device description
Amylase Reagent Kit for use with EasyRA Analyzers
Published
2019-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K080823000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080823000EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENTMedica Corp.2008-11-17JFJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00386100002138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00386100002138003861000021383861000021380386100002138

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-275-4892technicalsupport@medicacorp.com

Regulatory Flags#

DUNS number
112942404
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00386100002145ALB Reagent Kit10218-410218-42019-02-14
00386100002008CHOL Reagent Kit 10204-410204-42019-02-14
00386100002022SGOT (AST) Reagent Kit10206-410206-42019-02-14
00386100002039TBIL Reagent Kit10207-410207-42019-02-14
00386100002053CO2 Reagent Kit 10209-410209-42019-02-14
00386100002060Ca Reagent Kit 10210-410210-42019-02-14
00386100002077HDL CHOL Reagent Kit10211-410211-42019-02-14
00386100002084DBIL Reagent Kit 10212-410212-42019-02-14
00386100002107ALP Reagent Kit 10214-410214-42019-02-14
00386100002121TRIG Reagent Kit10216-410216-42019-02-14
00386100002169Mg Reagent Kit10220-410220-42019-02-14
00386100002176Phos Reagent Kit10221-410221-42019-02-14
00386100002183CK Reagent Kit 10222-410222-42019-02-14
00386100002190Iron (Fe) Reagent Kit10223-410223-42019-02-14
00386100002206LDL CHOL Reagent Kit 10224-410224-42019-02-14
00386100002213UALB Reagent Kit10225-410225-42019-02-14
00386100002237Lipase Reagent Kit 10227-410227-42019-02-20
00386100002244CRP Reagent Kit10228-410228-42019-02-14
00386100002268HbA1c Reagent Kit 10230-210230-22019-02-14
00386100002046Uric Reagent Kit 10208-410208-42019-02-14

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
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