FDA.reportPublic FDA data

VITROS

Primary DI
10758750001149
Brand
VITROS
Company
ORTHO CLINICAL DIAGNOSTICS
Model
6801390
Catalog number
6801390
Device description
VITROS Immunodiagnostic Products HBsAg Controls
Published
2020-04-01
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
MJXKit, serological, positive control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJXKit, Serological, Positive ControlClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030067000VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLSOrtho-Clinical Diagnostics2003-01-17MJX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750001146PackageGS130In Commercial Distribution
10758750001149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000114620758750001146
1075875000114910758750001149

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis B virus surface antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of Hepatitis B virus surface antigen in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00May be stored frozen
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
215865786
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10758750033287VITROS619773561977352020-05-16
10758750033294VITROS619557561955752020-05-16
10758750032891VITROS690004069000402025-12-30
10758750033522VITROS691223269122322025-12-30
10758750033539VITROS691223369122332025-12-30
10758750008322VITROS100940610094062020-04-08
10758750002061VITROS680215668021562015-12-22
10758750002504VITROS680230168023012015-12-22
10758750035366VITROS619945461994542025-05-20
10758750035373VITROS619945561994552025-05-20
10758750035380VITROS619945661994562025-05-20
20758750035363VITROS619945461994542025-05-20
20758750035370VITROS619945561994552025-05-20
20758750035387VITROS619945661994562025-05-20
10758750000203VITROS189683618968362016-08-26
10758750002801VITROS680245468024542014-10-22
10758750035465VITROS617444261744422023-11-22
10758750034420VITROS619996161999612021-11-08
10758750033355VITROS619991961999192021-03-22
10758750033362VITROS619992061999202021-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590745172ACCESS HIV Ag/Ab combo QCBeckman Coulter, Inc.MJX2024-03-15
00840733103476RSV Positive ControlMERIDIAN BIOSCIENCE, INC.MJX2021-06-18
00380740131364AlinityAbbott GmbHMJX2020-11-06
05055273216394SEROLOGY LYME DISEASE POSITIVE CONTROL (LYME CONTROL +)RANDOX LABORATORIES LIMITEDMJX2020-01-22
00816784020413ACCURUN®Lgc Clinical Diagnostics, Inc.MJX2018-09-24
00380740011161ARCHITECTAbbott GmbHMJX2016-09-09
00380740011178ARCHITECTAbbott GmbHMJX2016-09-09
00380740011185ARCHITECTAbbott GmbHMJX2016-09-09