FDA.reportPublic FDA data

AMY

Primary DI
05055273200652
Brand
AMY
Company
RANDOX LABORATORIES LIMITED
Model
AY7932
Catalog number
AY7932
Device description
An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, or urine.
Published
2016-09-09
Public version status
Update
Distribution status
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
CIJSaccharogenic, Amylase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CIJSaccharogenic, AmylaseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953211000AMYLASE (ETHYLIDENE PNGPG7) KITRandox Laboratories, Ltd.1996-06-21CIJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273200652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273200652050552732006525055273200652

GMDN Terms#

Term, Definition table
TermDefinition
Amylase isoenzyme IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple amylase isoenzymes in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Stable for at least 4 weeks in the instrument at approximately +10°C.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442894451070technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
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
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03
05055273200034ALBAB3800AB38002016-09-16
05055273200041ALBAB362AB3622016-09-16
05055273200058ALBAB3800AB38002016-09-16
05055273208115ALBAB8301AB83012016-09-16
05055273218985ConcizuTrace™ ELISACZM10591CZM105912025-05-30
05055273203400GLUTATHIONE REDUCTASE (GLUT RED)GR23682019-06-03
05055273203417GLUTATHIONE REDUCTASE CONTROL SERUM (GLUT RED CONTROL)GR26082019-06-03
05055273203424GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL)GR26092019-06-03
05055273205091RABSRP3857RP38572016-09-26
05055273205893RX daytonaRX3900RX39002018-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811727016034Pointe Amylase ReagentHORIBA INSTRUMENTS INCORPORATEDCIJ2021-01-30
00811727015723Pointe Amylase on BS480 AnalyzerHORIBA INSTRUMENTS INCORPORATEDCIJ2020-05-28
00852169008041ClearChem Diagnostics Inc. AmylaseCLEARCHEM DIAGNOSTICS INC.CIJ2018-04-30
00812137011879AMYLASE (CNPG3) Reagent SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.CIJ2016-10-12
00817439020192Amylase / BS480Medtest Dx, Inc.CIJ2016-09-27
00817439020215Amylase / BS200Medtest Dx, Inc.CIJ2016-09-27
00857969006228ACEALFA WASSERMANN, INC.CIJ2016-09-24
00015482771133SPOTCHEM™ II AmylaseARKRAY USA, INC.CIJ2016-09-23
00015482771157SPOTCHEM™ II ALPARKRAY USA, INC.CIJ2016-09-23
00015482771164SPOTCHEM™ II CreatinineARKRAY USA, INC.CIJ2016-09-23
EABA40000031Piccolo Liver Panel PlusABAXIS, INC.CIJ2016-09-23
EABA40000291Piccolo General Chemistry 13ABAXIS, INC.CIJ2016-09-23
EABA40000351Piccolo BioChemistry Panel PlusABAXIS, INC.CIJ2016-09-23
EABA40000411Piccolo AmLyte 13ABAXIS, INC.CIJ2016-09-23
05055273200560AMYRANDOX LABORATORIES LIMITEDCIJ2016-09-09
05055273200577AMYRANDOX LABORATORIES LIMITEDCIJ2016-09-09
05055273200584AMYRANDOX LABORATORIES LIMITEDCIJ2016-09-09
05055273200607AMYRANDOX LABORATORIES LIMITEDCIJ2016-09-09
05055273200645AMYRANDOX LABORATORIES LIMITEDCIJ2016-09-09
05055273200676AMYRANDOX LABORATORIES LIMITEDCIJ2016-09-09
00811727010285POINTE SCIENTIFIC AmylaseHORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727010292POINTE SCIENTIFIC AmylaseHORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727010308POINTE SCIENTIFIC AMYLASEHORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727010315POINTE SCIENTIFIC AMYLASEHORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727012562Pointe Scientfic, Inc.HORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727012906Pointe ScientificHORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727013422POINTE SCIENTIFIC AmylaseHORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727013835Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727014641Pointe Scientific, Inc. AmylaseHORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727014931Pointe Scientific, Inc. AmylaseHORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31