FDA.reportPublic FDA data

POINTE SCIENTIFIC Ammonia Standard 1

Primary DI
00811727010261
Brand
POINTE SCIENTIFIC Ammonia Standard 1
Company
HORIBA INSTRUMENTS INCORPORATED
Model
A7553-STD100
Catalog number
A7553-STD100
Device description
The Ammonia Standards are intended for the calibration of ammonia assays.
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
JIFEnzymatic Method, Ammonia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIFEnzymatic Method, AmmoniaClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864706000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864706000RAICHEM(TM) AMMONIA REAGENTReagents Applications, Inc.1987-01-05JIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811727010261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727010261008117270102618117270102610811727010261

GMDN Terms#

Term, Definition table
TermDefinition
Ammonia IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of ammonia in a clinical specimen.

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
00845275000016Infinity Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers Fisher DiagnosticsJIF2025-11-18
08058056680181Ammonia Ultra SENTINEL CH. SPAJIF2023-11-22
04015630914708AmmoniaRoche Diagnostics GmbHJIF2021-02-08
04015630927005AmmoniaRoche Diagnostics GmbHJIF2021-02-08
04015630928071AmmoniaRoche Diagnostics GmbHJIF2021-02-08
00630414555898ADVIA® Chemistry AMM Ammonia ReagentsSiemens Healthcare Diagnostics Inc.JIF2020-09-24
00630414595832Atellica CH AmmSiemens Healthcare Diagnostics Inc.JIF2020-09-24
00630414948102Dimension Vista® Flex® reagent cartridge AMMSiemens Healthcare Diagnostics Inc.JIF2020-09-24
00630414948096Dimension® Flex® reagent cartridge AMMSiemens Healthcare Diagnostics Inc.JIF2020-09-24
07613336121429Ammonia IIRoche Diagnostics GmbHJIF2020-03-05
05055273200256AMMONIA (NH3)RANDOX LABORATORIES LIMITEDJIF2019-06-04
05055273200263AMMONIA (NH3)RANDOX LABORATORIES LIMITEDJIF2019-06-04
04015630936533Ammonia IIRoche Diagnostics GmbHJIF2019-05-10
04015630936526Ammonia IIRoche Diagnostics GmbHJIF2019-03-26
05055273200270NH3RANDOX LABORATORIES LIMITEDJIF2018-12-24
00817238011247Ammonia StandardCLINIQA CORPORATIONJIF2018-08-23
00817238011438Ammonia ReagentCLINIQA CORPORATIONJIF2018-08-23
00380740010768ARCHITECTABBOTT LABORATORIESJIF2018-07-31
00380740010775ARCHITECTABBOTT LABORATORIESJIF2018-07-31
00380740136192AlinityABBOTT LABORATORIESJIF2018-07-30
00845275005400Thermo Scientific Infinity™ for Beckman Coulter SYNCHRON SystemsFisher DiagnosticsJIF2016-09-16
00628063400010Ammonia L3KSEKISUI DIAGNOSTICS, LLCJIF2016-09-16
00811727010247POINTE SCIENTIFIC AMMONIAHORIBA INSTRUMENTS INCORPORATEDJIF2016-08-31
00811727010254POINTE SCIENTIFIC AMMONIAHORIBA INSTRUMENTS INCORPORATEDJIF2016-08-31
00811727010278POINTE SCIENTIFIC Ammonia Standard 5HORIBA INSTRUMENTS INCORPORATEDJIF2016-08-31
15099590222635SynchronBeckman Coulter, Inc.JIF2016-08-24