FDA.reportPublic FDA data

DYNEX DS2

Primary DI
05060456180317
Brand
DYNEX DS2
Company
DYNEX TECHNOLOGIES, INC.
Model
62000
Catalog number
62000
Device description
DS2 Automated ELISA Processing System
Published
2022-02-07
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
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
JQWStation, Pipetting And Diluting, For Clinical Use
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClinical Chemistry1
JQWStation, Pipetting And Diluting, For Clinical UseClinical Chemistry1
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060456180314PackageGS11In Commercial Distribution
05060456180317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506045618031415060456180314
05060456180317050604561803175060456180317

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
703 603 7800customerservice@dynex.com

Regulatory Flags#

DUNS number
170119536
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060456180058DYNEX Agility67000670002022-02-07
05060456180287DYNEX DSX65100651002022-02-07
05060456180348DIALISA 2MP62003620032022-02-07
05060456180003DYNEX DS262010620102022-02-07
15060456180055DYNEX Agility67000670002022-02-07
15060456180284DYNEX DSX65100651002022-02-07
15060456180314DYNEX DS262000620002022-02-07
15060456180345DIALISA 2MP62003620032022-02-07

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Primary DI, Brand, Company table
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20885380197861CARDINAL HEALTHCardinal Health 200, LLCLXG2025-04-18
20885380197878CARDINAL HEALTHCardinal Health 200, LLCLXG2025-04-18
20885380197885CARDINAL HEALTHCardinal Health 200, LLCLXG2025-04-18
20885380197892CARDINAL HEALTHCardinal Health 200, LLCLXG2025-04-18
20885380197915CARDINAL HEALTHCardinal Health 200, LLCLXG2025-04-18
15099590798215DxHBeckman Coulter, Inc.LXG2025-04-04
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