FDA.reportPublic FDA data

Ammonia Ultra

Primary DI
08058056680181
Brand
Ammonia Ultra
Company
SENTINEL CH. SPA
Model
17660
Catalog number
17660
Device description
The Ammonia Ultra assay is intended for the in vitro quantitative enzymatic determination of ammonia in human plasma using an automated analyzer.Measurements of ammonia are used to aid in the diagnosis of patients suspected of having hyperammonemia.For laboratory professional use only.
Published
2023-11-22
Public version status
New
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
K051114000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051114000SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAYSentinel Ch. Srl2005-11-25JIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058056680181PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058056680181080580566801818058056680181

GMDN Terms#

Term, Definition table
TermDefinition
Ammonia IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of ammonia in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store between 2 and 8 degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999customerservice@sentinel.it

Regulatory Flags#

DUNS number
429572365
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
08058056681232CeruloplasminA26842A268422016-07-29
08058056685391Cystatin C Calibrators06T320106T32012025-09-16
08058056685407Cystatin C Controls06T321006T32102025-09-16
08058056685414Cystatin C06T322006T32202025-09-16
08058056685421Cystatin C06T323006T32302025-09-16
08058056681973Albumin BCP (6x20 mL)C22855C228552020-02-24
08058056681980Albumin BCP (6x50 mL)C22856C228562020-02-24
08058056685438ARCHITECT c ACE Assay File6U82-1A6U82-1A2025-03-10
08058056685445Alinity c ACE Assay File06U86-1A06U86-1A2025-03-10
08058056685285ACE Calibrator06U820106U82012025-01-27
08058056685292ACE Control06U821006U82102025-01-27
08058056685308ACE Reagent06U822506U82252025-01-27
08058056685315ACE Calibrator06U860106U86012025-01-27
08058056685322ACE Control06U861006U86102025-01-27
08058056685339ACE Reagent06U862506U86252025-01-27
08058056680211Lp(a) Ultra11504D11504D2024-03-15
08058056680228Lp(a) Cal Set11522D11522D2024-03-15
08058056681744Lp(a) Control Set115220111522012024-03-15
08058056680617Lipase Color Liquid17401B17401B2017-01-16
08058056681911CRP Ultra (MP)1156461156462018-02-27

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