FDA.reportPublic FDA data

Emit® tox™ Salicylic Acid Assay

Primary DI
00842768023347
Brand
Emit® tox™ Salicylic Acid Assay
Company
Siemens Healthcare Diagnostics Inc.
Model
10445394
Catalog number
7S229
Device description
Emit® tox Salicylic Acid Assay labeled with the Beckman Coulter® name
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DKJCOLORIMETRY, SALICYLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKJColorimetry, SalicylateClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011878000EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULSyva Co.2001-08-13DKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768023347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768023347008427680233478427680233470842768023347

GMDN Terms#

Term, Definition table
TermDefinition
Salicylate IVD, kit, enzyme immunoassay (EIA)A 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 an enzyme immunoassay (EIA) method.

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
+1(800)227-8994XX@XX.XX
+1(800)227-8994CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
1
Lot or batch
true
Expiration date on label
true

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00630414513102ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III)10341116103411162016-09-24
00630414517742ADVIA® Chemistry C4 Complement C4 Reagents10309054103090542016-09-24
00630414590394ADVIA® Chemistry TRIG_c Reagent10697575106975752016-09-24
00630414601199ADVIA® Chemistry Alkaline Phosphatase (ALP_2) Calibrator10916060109160602016-09-24
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00630414534794ADVIA® 1800 Analyzer10315183103151832020-09-24
00630414000510VERSANT HCV Control 2.0 Kit (LiPA)10719668107196682017-09-15
00630414454597ADVIA Centaur® FOL10331250103312502016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.10309442103094422018-12-01
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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
00628063401123Salicylate AssaySekisui Diagnostics, LLCDKJ2018-11-28
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
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