FDA.reportPublic FDA data

DYNEX DS2

Primary DI
05060456180003
Brand
DYNEX DS2
Company
DYNEX TECHNOLOGIES, INC.
Model
62010
Catalog number
62010
Device description
DS2 Automated ELISA Processing System, with Barcode Scanner
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
15060456180000PackageGS11In Commercial Distribution
05060456180003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506045618000015060456180000
05060456180003050604561800035060456180003

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, laboratory, automatedAn electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or more technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
703 631 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
05060456180317DYNEX DS262000620002022-02-07
05060456180348DIALISA 2MP62003620032022-02-07
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
Primary DIBrandCompanyProduct codePublished
08435389828150SAMPLE PREPARATION KITBIOTECHNOLOGY INSTITUTE SLLXG2026-05-27
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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
40197344006060MedlineMEDLINE INDUSTRIES, INC.LXG2024-07-08
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00810044207378Caplugs/EvergreenCAPlugsJQW2024-05-31
00810044207385Caplugs/EvergreenCAPlugsJQW2024-05-31
00810044207392Caplugs/EvergreenCAPlugsJQW2024-05-31