FDA.reportPublic FDA data

ORTHO

Primary DI
10758750030149
Brand
ORTHO
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
6904630
Catalog number
6904630
Device description
ORTHO™ Workstation ID-MTS Gel
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KSNCENTRIFUGE, CELL-WASHING, AUTOMATED FOR IMMUNO-HEMATOLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSNCentrifuge, Cell-Washing, Automated For Immuno-HematologyHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10758750030149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075875003014910758750030149

GMDN Terms#

Term, Definition table
TermDefinition
Gel column agglutination centrifuge IVDAn electrically-powered device intended to be used in a clinical laboratory setting for the centrifugation of gel column agglutination cards used to perform manual blood typing assays. It is a dedicated compact benchtop unit with an electric motor, a shaft, a rotor with slots specifically shaped for use with gel column cards, and speed and time controls. The device is intended to centrifuge gel column agglutination cards for the manual determination of antigens of multiple blood systems (e.g., ABO, Rh, Kell) for compatibility testing and detection of unexpected antibodies.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-15 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
068715424
Device count
1
Combination product
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10758750000340VITROS194392719439272020-05-16
10758750012824ORTHO690457769045762017-03-23
10758750012817ORTHO690457769045772016-08-24
10758750003020BIOCLONE7112207112202014-10-22
10758750003075BIOCLONE7113207113202014-10-22
10758750003129BIOCLONE7115207115202014-10-22
10758750003198BIOCLONE7130807130802014-10-22
10758750003259BIOCLONE7131807131802014-10-22
10758750003266BIOCLONE7140807140802014-10-22
10758750003297BIOCLONE7141807141802014-10-22
10758750003389BIOCLONE7152807152802014-10-22
10758750003662BIOCLONE7173807173802014-10-22
10758750003822ORTHO7190007190002014-10-22
10758750003839SURGISCREEN7191007191002014-10-22
10758750003877AFFIRMAGEN7192017192012014-10-22
10758750003907AFFIRMAGEN7192107192102014-10-22
10758750003914AFFIRMAGEN7192117192112014-10-22
10758750003952ORTHO7193107193102014-10-22
10758750003976RESOLVE7194107194102014-10-22
10758750003990RESOLVE7195107195102014-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816394020933UltraCW®II HELMER, INC.KSN2018-04-13
10850685007002Thermo ScientificThermo Electron LED GmbHKSN2017-03-24
10816934020772Thermo Scientific Sorvall Blood Washing SystemKEY SCIENTIFIC INCKSN2016-09-23
10816934020789Thermo Scientific Sorvall Blood Cell Washing SystemKEY SCIENTIFIC INCKSN2016-09-23
10758750005802MTSMICRO TYPING SYSTEMS, INCKSN2016-08-24
00816394020902UltraCW® HELMER, INC.KSN2016-07-01