FDA.reportPublic FDA data

VITROS

Primary DI
10758750008773
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
1314343
Catalog number
1314343
Device description
VITROS Chemistry Products SALI Slides
Published
2016-08-26
Public version status
Update
Distribution status
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
20758750008770PackageGS130In Commercial Distribution
10758750008773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000877020758750008770
1075875000877310758750008773

GMDN Terms#

Term, Definition table
TermDefinition
Salicylate IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of salicylate in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-18 Degrees Celsius-18 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
623873044
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10758750035656VITROS627222262722222025-05-21
10758750005345ORTHO9337309337302025-02-17
10758750005031VITROS856804085680402016-08-10
10758750005352ORTHO934090F934090F2016-08-24
10758750030149ORTHO690463069046302016-08-24
10758750000067VITROS179235717923572020-06-06
10758750000388VITROS198821119882112016-08-23
10758750000593VITROS680012068001202016-08-10
10758750000616VITROS680018968001892016-08-23
10758750001354VITROS680176768017672016-08-26
10758750001743VITROS680198868019882016-08-10
10758750001750VITROS680198968019892016-08-23
10758750001774VITROS680199168019912016-08-23
10758750001811VITROS680199568019952016-08-23
10758750001828VITROS680199668019962016-08-26
10758750001835VITROS680199768019972016-08-26
10758750001842VITROS680199868019982016-08-26
10758750002283VITROS680221468022142016-08-26
10758750002290VITROS680221668022162016-08-23
10758750002535VITROS680230468023042016-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04015630992256SalicylateRoche Diagnostics GmbHDKJ2016-09-23
00657498001011Salicylate Liqui-UV®STANBIO LABORATORY, L.P.DKJ2016-09-23
00628063400867SALICYLATE-SL AssaySEKISUI DIAGNOSTICS, LLCDKJ2016-09-16
00884883001145DRI Salicylate Serum Tox AssayMicrogenics CorporationDKJ2016-09-12
00380740005290ARCHITECTABBOTT LABORATORIESDKJ2016-09-09
00380740005306ARCHITECTABBOTT LABORATORIESDKJ2016-09-09
15099590222116SynchronBeckman Coulter, Inc.DKJ2016-08-24