FDA.reportPublic FDA data

Ammonia Standard

Primary DI
00817238011247
Brand
Ammonia Standard
Company
CLINIQA CORPORATION
Model
R85406
Device description
Ammonia Standard
Published
2018-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JIFEnzymatic Method, Ammonia

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817238011247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817238011247008172380112478172380112470817238011247

GMDN Terms#

Term, Definition table
TermDefinition
Ammonia IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of ammonia in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078742335
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
00817238010257LiquidQC NEPHROCHECK Control 839382024-06-05
00817238010332NEPHROCHECK Calibration Verification839392024-06-05
00817238010264NEPHROCHECK® Method Validation For VIDAS® 3839402019-01-29
00817238010271LIQUID QC LIPID CONTROL LEVEL 915012018-08-23
00817238010288LIQUID QC LIPID CONTROL LEVEL 2 915022018-08-23
00817238010295LIQUID QC LIPID CONTROL Bi-level 915052018-08-23
00817238011520LQC Cardiac Control CS, mini pack914492022-11-19
00817238011056hsCRP Wide Range Reagent855502018-08-23
00817238010103Tumor Marker Control level 3913032018-08-22
00817238010110Tumor Marker Control level 1 913012018-08-22
00817238010127Tumor Marker Control level 2913022018-08-22
00817238010134Tumor Marker Control Tri-level913042018-08-22
00817238010141ImmuTROL Serum Protein Contrl Tri-Level (Level 1,2 & 3)911042018-08-22
00817238010158Tumor Marker Control Tri-level913092018-08-22
00817238010172ImmuTROL Serum Protein Control-Bi-Level (Level 1 & 3)911052018-08-22
00817238010189ImmuTROL Serum Protein Contrl Level 1911012018-08-22
00817238010196ImmuTROL Serum Protein Contrl Level 2911022018-08-22
00817238010202ImmuTROL Serum Protein Contrl Level 3911032018-08-22
00817238010219hsCRP Serum Protein Control Level 1912012018-08-22
00817238010226hsCRP Serum Protein Control Level 2912022018-08-22

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
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
00811727010261POINTE SCIENTIFIC Ammonia Standard 1HORIBA INSTRUMENTS INCORPORATEDJIF2016-08-31
00811727010278POINTE SCIENTIFIC Ammonia Standard 5HORIBA INSTRUMENTS INCORPORATEDJIF2016-08-31
15099590222635SynchronBeckman Coulter, Inc.JIF2016-08-24