FDA.reportPublic FDA data

Ammonia L3K

Primary DI
00628063400010
Brand
Ammonia L3K
Company
SEKISUI DIAGNOSTICS, LLC
Model
293-10
Catalog number
293-10
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K033921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033921000AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10Diagnostic Chemicals , Ltd.2004-03-10JIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628063400010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628063400010006280634000106280634000100628063400010

GMDN Terms#

Term, Definition table
TermDefinition
Ammonia IVD, kit, enzyme 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 an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
966812344
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
00742860100413Acucy Printer Paper10192026-02-27
10742860100410Acucy Printer Paper10192026-02-27
00742860100444Acucy Reader A/C Adapter10432026-02-27
00742860100475Acucy System Universal Drawer10512026-02-27
00742860100680OSOM BVBlue Transport Swabs1862026-02-23
50742860100685OSOM BVBlue Transport Swabs1862026-02-23
00742860100338Acucy System10392019-09-24
00742860100673OSOM COVID-19 Test109210922026-01-19
10742860100670OSOM COVID-19 Test109210922026-01-19
00742860100055OSOM BV Blue 25T Kit1831832025-12-29
10742860100052OSOM BV Blue 25T Kit1831832025-12-29
00742860100062OSOM BV Blue Control Kit1841842025-12-29
00742860100666OSOM RSV Test Home109110912025-05-19
00742860000065OSOM Flu SARS-CoV-2 Combo Test10802024-12-16
00628063400058ALBUMIN Assay200-05200-052016-09-16
00628063400065ALBUMIN Assay200-45200-452016-09-16
00628063400072ALBUMINSK200-10SK200-102016-09-20
10742860100663OSOM RSV Test Home109110912025-05-19
00742860000027OSOM COVID-19 Antigen Rapid Test1066-401066-402024-12-16
00742860000034OSOM COVID-19 Antigen Control Kit106810682024-12-16

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
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