FDA.reportPublic FDA data

ORTHO

Primary DI
10758750005420
Brand
ORTHO
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
936380F
Catalog number
936380F
Device description
AutoWash 96, SLT/AutoWash 96, SLT, Refurbished
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
MZATEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZATest, Equipment, Automated Bloodborne PathogenUnknownN

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1300060

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1300060

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10758750005420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075875000542010758750005420

GMDN Terms#

Term, Definition table
TermDefinition
Microplate washer IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for washing microplates containing multiple individual sample wells (i.e., the removal of biological specimen residue, stains, or impurities) by dispensing and aspirating measured volumes of washing solution as part of the processing required to perform an in vitro diagnostic assay.

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
07613336206355cobas® 6800 systemRoche Molecular Systems, Inc.MZA2026-03-26
07613336206362cobas® 8800 systemRoche Molecular Systems, Inc.MZA2026-03-26
00380740157166AlinityAbbott Ireland DiagnosticsMZA2024-07-18
00380740157173AlinityAbbott Ireland DiagnosticsMZA2024-07-18
00380740198930AlinityAbbott GmbHMZA2024-01-17
00380740162887AlinityAbbott GmbHMZA2019-11-30
00380740162863AlinityAbbott GmbHMZA2019-10-12
00380740162917AlinityAbbott GmbHMZA2019-10-12
00380740162894AlinityAbbott GmbHMZA2019-09-28
00380740162924AlinityAbbott GmbHMZA2019-09-14
00380740162931AlinityAbbott GmbHMZA2019-09-14
00380740162948AlinityAbbott GmbHMZA2019-09-14
00380740118181AlinityAbbott Ireland DiagnosticsMZA2019-07-26
00380740129613AlinityABBOTT LABORATORIESMZA2019-07-26
00380740136895AlinityAbbott Ireland DiagnosticsMZA2019-07-26
00380740138479AlinityABBOTT LABORATORIESMZA2019-07-26
00380740156817AlinityABBOTT LABORATORIESMZA2019-07-26
00380740156831AlinityABBOTT LABORATORIESMZA2018-10-03
00380740118167AlinityAbbott Ireland DiagnosticsMZA2018-05-31
00380740118174AlinityAbbott Ireland DiagnosticsMZA2018-05-31
00380740129026AlinityABBOTT LABORATORIESMZA2018-05-31
00380740132705AlinityABBOTT LABORATORIESMZA2018-05-31
00380740007904ABBOTT PRISMABBOTT LABORATORIESMZA2016-09-09
00380740007911ABBOTT PRISMABBOTT LABORATORIESMZA2016-09-09
00380740012403ABBOTT PRISMABBOTT LABORATORIESMZA2016-09-09
00380740050375ABBOTT PRISMABBOTT LABORATORIESMZA2016-09-09
10758750005352ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.MZA2016-08-24
10758750005451ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.MZA2016-08-24
10758750005581ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.MZA2016-08-24
10758750007523ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.MZA2016-08-24