FDA.reportPublic FDA data

Salicylate

Primary DI
04015630992256
Brand
Salicylate
Company
Roche Diagnostics GmbH
Model
11815172216
Catalog number
11815172216
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
04015630992256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630992256040156309922564015630992256

GMDN Terms#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
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07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
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07613336218341Elecsys CA 19-909755608190097556081902026-06-01
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07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
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07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
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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
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
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