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
OTC
false
Sterile
false
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
Alpha-amylase isoenzyme IVD, reagentA substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an alpha-amylase isoenzyme (e.g., salivary or pancreatic) and/or to determine its enzymatic activity 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 Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
227530649
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055273200560AMYAY1580AY15802016-09-09
05055273200577AMYAY1582AY15822016-09-09
05055273200584AMYAY2811AY28112016-09-09
05055273200591P AMYAY2862AY28622016-09-09
05055273200607AMYAY3805AY38052016-09-09
05055273200614P AMYAY3855AY38552016-09-09
05055273200645AMYAY7931AY79312016-09-09
05055273200669P AMYAY7934AY79342016-09-09
05055273200676AMYAY9707AY97072016-09-09
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

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