FDA.reportPublic FDA data

VITROS

Primary DI
10758750008322
Brand
VITROS
Company
ORTHO CLINICAL DIAGNOSTICS
Model
1009406
Catalog number
1009406
Device description
VITROS Immunodiagnostic Products RE Controls
Published
2020-04-08
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
JJYMulti-analyte controls, all kinds (assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K965048000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K965048000VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)Johnson & Johnson Clinical Diagnostics, Inc.1997-01-27JJY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750008329PackageGS130In Commercial Distribution
10758750008322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000832920758750008329
1075875000832210758750008322

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-fetoprotein (AFP) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00May be stored frozen, avoid repeated freeze-thaw cycles
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
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
10758750034413VITROS619996061999602021-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391523442831Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442848Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442855Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442862Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442879Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442886Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442893Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442909Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442916Multichem NBTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442923Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442930Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
00884883009080MAS Immunology Advanced Sample PackMicrogenics CorporationJJY2026-05-27
00884883011373MAS Immunology Advanced Level 1Microgenics CorporationJJY2026-05-27
00884883011380MAS Immunology Advanced Level 2Microgenics CorporationJJY2026-05-27
00884883011397MAS Immunology Advanced Level 3Microgenics CorporationJJY2026-05-27
00884883011427CRP (C-Reactive Protein)Microgenics CorporationJJY2026-05-27
00850028489048TriVerity Level 1 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489055TriVerity Level 2 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489093TriVerity Verification PanelInflammatix, Inc.JJY2026-04-30
00850028489109TriVerity Mini Verification PanelInflammatix, Inc.JJY2026-04-30
00850011135747VALIDATELgc Clinical Diagnostics, Inc.JJY2026-04-24
00850075957330KOVA-Trol II Low AbnormalLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957378KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957385KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957392KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957408KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957415KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957439KOVA-Trol I High Abnormal with Urobilinogen Value AssignmentLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850011135822VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08
00850011135839VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08