FDA.reportPublic FDA data

AMY

Primary DI
05055273200577
Brand
AMY
Company
RANDOX LABORATORIES LIMITED
Model
AY1582
Catalog number
AY1582
Device description
The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine.
Published
2016-09-09
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
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
05055273200577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273200577050552732005775055273200577

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 21 days at +2 to + 8°C once reconstituted.
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
05055273200584AMYRANDOX LABORATORIES LIMITEDCIJ2016-09-09
05055273200607AMYRANDOX LABORATORIES LIMITEDCIJ2016-09-09
05055273200645AMYRANDOX LABORATORIES LIMITEDCIJ2016-09-09
05055273200652AMYRANDOX 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