FDA.reportPublic FDA data

Pointe Scientific, Inc.

Primary DI
00811727012876
Brand
Pointe Scientific, Inc.
Company
HORIBA INSTRUMENTS INCORPORATED
Model
HA916-302
Catalog number
HA916-302
Device description
Alkaline Phosphatase Reagent, for the quantitative determination of alkaline phosphatase in human serum on Hitachi analyzers. For in vitro diagnostic use only. Size: 5 x 50mL, 4 x 13mL
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
CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CJENitrophenylphosphate, Alkaline Phosphatase Or IsoenzymesClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973588000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973588000LIQUID ALKALINE PHOSHATASE REAGENT SETPointe Scientific, Inc.,1997-10-22CJE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811727012876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727012876008117270128768117270128760811727012876

GMDN Terms#

Term, Definition table
TermDefinition
Total alkaline phosphatase (ALP) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total alkaline phosphatase (ALP) 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
00850053916014IDG/SanzayIDG/SANZAY CorporationCJE2024-01-03
10673486001044Alkaline Phosphatase (ALP) Kinetic Method TC Matrix-240/480TECO DIAGNOSTICSCJE2023-07-14
10673486001051Alkaline Phosphatase (Kinetic Procedure)TECO DIAGNOSTICSCJE2023-07-14
10673486001068Alkaline Phosphatase (Kinetic Procedure)TECO DIAGNOSTICSCJE2023-07-14
10673486002362Alkaline Phosphatase Liquid Reagent (Kinetic Procedure)TECO DIAGNOSTICSCJE2023-07-14
00811727016010Pointe Alkaline Phosphatase ReagentHORIBA INSTRUMENTS INCORPORATEDCJE2021-01-30
00811727015709Pointe Alkaline Phosphatase on the BS480HORIBA INSTRUMENTS INCORPORATEDCJE2020-05-28
03610230006832Yumizen C1200 ALPHORIBA ABX SASCJE2020-05-06
07613336120972Alkaline phosphatase acc. to IFCC Gen.2Roche Diagnostics GmbHCJE2020-03-05
10758750031801VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CJE2019-11-13
05055273208207ALKALINE PHOSPHATASE (ALP)RANDOX LABORATORIES LIMITEDCJE2019-06-03
00386100002107ALP Reagent Kit MEDICA CORPORATIONCJE2019-02-14
00628063401192Alkaline PhosphataseSEKISUI DIAGNOSTICS, LLCCJE2018-11-28
00380740135164AlinityAbbott GmbHCJE2018-06-06
00380740135171AlinityAbbott GmbHCJE2018-06-06
00852169008027ClearChem Diagnostics Inc. Alkaline Phosphatase (ALP)CLEARCHEM DIAGNOSTICS INC.CJE2018-04-30
00380740150891ARCHITECTAbbott GmbHCJE2017-05-30
00380740150907ARCHITECTAbbott GmbHCJE2017-05-30
00817274022436JAS DiagnosticsDREW SCIENTIFIC, INC.CJE2017-03-23
00817274022443JAS DiagnosticsDREW SCIENTIFIC, INC.CJE2017-03-23
05060500091699Synermed®INFRARED LABORATORY SYSTEMS LLCCJE2017-02-28
00817302023015CAROLINA LIQUID CHEMISTRIES CORP.® ALP REAGENT PRODUCT NO. DT206CAROLINA LIQUID CHEMISTRIES CORPORATIONCJE2016-10-17
00812137011855Alkaline Phosphatase Reagent SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.CJE2016-10-12
00817439020123Alkaline Phos/ BS480Medtest Dx, Inc.CJE2016-09-27
00817439020130ALP ReagentMedtest Dx, Inc.CJE2016-09-27
00817439020147MedTest DX Alkaline PhosphataseMedtest Dx, Inc.CJE2016-09-27
15099590000028AUBeckman Coulter, Inc.CJE2016-09-24
15099590010034AUBeckman Coulter, Inc.CJE2016-09-24
15099590020019AUBeckman Coulter, Inc.CJE2016-09-24
15099590060015AUBeckman Coulter, Inc.CJE2016-09-24