FDA.reportPublic FDA data

DIALISA 2MP

Primary DI
05060456180348
Brand
DIALISA 2MP
Company
DYNEX TECHNOLOGIES, INC.
Model
62003
Catalog number
62003
Device description
DIALISA 2MP, 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
15060456180345PackageGS11In Commercial Distribution
05060456180348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506045618034515060456180345
05060456180348050604561803485060456180348

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
703 631 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
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
Primary DIBrandCompanyProduct codePublished
08435389828150SAMPLE PREPARATION KITBIOTECHNOLOGY INSTITUTE SLLXG2026-05-27
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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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