FDA.reportPublic FDA data

Pointe Scientific, Inc.

Primary DI
00811727013835
Brand
Pointe Scientific, Inc.
Company
HORIBA INSTRUMENTS INCORPORATED
Model
13-A7564-30
Catalog number
13-A7564-30
Device description
Reagent for the quantitative kinetic determination of a-amylase activity in human serum using a manual or automated procedure.1 x 30 ml
Published
2016-08-31
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
CIJSaccharogenic, Amylase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CIJSaccharogenic, AmylaseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940735000LIQUID AMYLASE (CNPG3) REAGENT SETPointe Scientific, Inc.,1994-08-01CIJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811727013835PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727013835008117270138358117270138350811727013835

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
800-445-9853techservice@medtest.com

Regulatory Flags#

DUNS number
052845583
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
00811727018977POINTE Chemistry Calibrator SetC7506-15C7506-152026-05-01
00811727015716Pointe ALT for the BS48014-A7526-37514-A7526-3752020-05-28
00811727015747Pointe BUN on BS48014-B7552-60014-B7552-6002020-05-28
00811727015761Pointe Creatinine Enzymatic on BS48014-C7548-21614-C7548-2162020-05-28
00811727015785Pointe Creatine Kinase for BS48014-C7522-22014-C7522-2202020-05-28
00811727015808Pointe Creatinine for BS48014-C7539-43214-C7539-4322020-05-28
00811727015822Pointe Direct Bilirubin for BS48014-HB936-20014-HB936-2002020-05-28
00811727015853Pointe HbA1c for the BS48014-H7546-16014-H7546-1602020-05-28
00811727015709Pointe Alkaline Phosphatase on the BS48014-A7516-22514-A7516-2252020-05-28
00811727015723Pointe Amylase on BS480 Analyzer14-A7564-12014-A7564-1202020-05-28
00811727015730Pointe AST on the BS480 Analyzer14-A7561-37514-A7561-3752020-05-28
00811727015754Pointe Calcium Arsenazo for BS48014-C7529-36014-C7529-3602020-05-28
00811727015778Pointe Cholesterol on BS48014-C7510-48014-C7510-4802020-05-28
00811727015792Pointe Carbon Dioxide on the BS48014-C7502-16014-C7502-1602020-05-28
00811727015839Pointe GGT on BS48014-G7571-20014-G7571-2002020-05-28
00811727015846Pointe Glucose Hexokinase for BS48014-G7517-48014-G7517-4802020-05-28
00811727015860Pointe autoHDL for the BS48014-H7545-30014-H7545-4002020-05-28
00811727015877Pointe Homocysteine for BS48014-H7575-14414-H7575-1442020-05-28
00811727015884Pointe Total Iron for the BS48014-HI904-35014-HI904-3502020-05-28
00811727015693Pointe Albumin on BS480 Analyzer14-A7502-48014-A7502-4802020-05-28

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
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
00811727014641Pointe Scientific, Inc. AmylaseHORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31
00811727014931Pointe Scientific, Inc. AmylaseHORIBA INSTRUMENTS INCORPORATEDCIJ2016-08-31