FDA.reportPublic FDA data

Salicylate Assay

Primary DI
00628063401123
Brand
Salicylate Assay
Company
Sekisui Diagnostics, LLC
Model
SK511-50
Catalog number
SK511-50
Published
2018-11-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DKJCOLORIMETRY, SALICYLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKJColorimetry, SalicylateClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628063401123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628063401123006280634011236280634011230628063401123

GMDN Terms#

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

Regulatory Flags#

DUNS number
966812344
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

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00742860100376Acucy Flu Test Kit10102019-08-20
00742860100383Acucy Influenza A&B Control Kit10112019-08-23
00742860000027OSOM COVID-19 Antigen Rapid Test1066-401066-402024-12-16
00742860000034OSOM COVID-19 Antigen Control Kit106810682024-12-16
00742860000041OSOM COVID-19 Antigen Home Test1067-401067-402024-12-16
00742860000072OSOM Flu SARS-CoV-2 Combo Control Kit10792024-12-16
00742860000089OSOM Flu SARS-CoV-2 Combo Home107410742024-12-16
00742860100055OSOM BV Blue 25T Kit1831832025-12-29
00742860100314OSOM Vaginal Transport Swab Set1851852018-04-05
00742860100390OSOM ULTRA PLUS FLU A&B Test10322020-06-01
00742860100406OSOM ULTRA PLUS FLU A&B Control Kit10342020-06-01
00742860100673OSOM COVID-19 Test109210922026-01-19
00742860100680OSOM BVBlue Transport Swabs1862026-02-23
00742860100062OSOM BV Blue Control Kit1841842025-12-29
00742860000065OSOM Flu SARS-CoV-2 Combo Test10802024-12-16
00628063401291Acetaminophen03R74202023-05-08
00628063401307Acetaminophen Calibrator03R74012023-05-08
00628063401314Alinity c Acetaminophen07P54202023-05-08
00628063401321Alinity c Acetaminophen Calibrator07P54012023-05-08
00628063401222DC-TROL LEVELS 1 & 2SM-0572020-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654256Atellica CH Salicylate (SalC)Siemens Healthcare Diagnostics Inc.DKJ2025-10-15
07613336121504SalicyclateRoche Diagnostics GmbHDKJ2020-03-05
00380740135614AlinityABBOTT LABORATORIESDKJ2018-08-08
00630414595887Atellica CH SalSiemens Healthcare Diagnostics Inc.DKJ2017-12-27
05055273209396SALRANDOX LABORATORIES LIMITEDDKJ2016-09-24
00842768001611Syva® Emit® tox™ Salicylic Acid AssaySiemens Healthcare Diagnostics Inc.DKJ2016-09-24
00842768005435Dimension® Flex® reagent cartridge SALSiemens Healthcare Diagnostics Inc.DKJ2016-09-24
00842768015427Dimension Vista® Flex® reagent cartridge SALSiemens Healthcare Diagnostics Inc.DKJ2016-09-24
00842768023347Emit® tox™ Salicylic Acid AssaySiemens Healthcare Diagnostics Inc.DKJ2016-09-24
00884883001152DRI Salicylate Calibrator KitMicrogenics CorporationDKJ2016-09-24
00630414498959ADVIA® Chemistry SAL Salicylate ReagentsSiemens Healthcare Diagnostics Inc.DKJ2016-09-24
04015630992256SalicylateRoche Diagnostics GmbHDKJ2016-09-23
00657498001011Salicylate Liqui-UV®STANBIO LABORATORY, L.P.DKJ2016-09-23
04015630915897SalicylateRoche Diagnostics GmbHDKJ2016-09-20
00628063400867SALICYLATE-SL AssaySekisui Diagnostics, LLCDKJ2016-09-16
00884883001145DRI Salicylate Serum Tox AssayMicrogenics CorporationDKJ2016-09-12
00380740005290ARCHITECTABBOTT LABORATORIESDKJ2016-09-09
00380740005306ARCHITECTABBOTT LABORATORIESDKJ2016-09-09
10758750008773VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DKJ2016-08-26
15099590222116SynchronBeckman Coulter, Inc.DKJ2016-08-24