FDA.reportPublic FDA data

VITROS

Primary DI
10758750000630
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
6800191
Catalog number
6800191
Device description
VITROS Chemistry Products UPRO Performance Verifier II
Published
2020-05-29
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
JGPLOWRY (COLORIMETRIC), TOTAL PROTEIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JGPLowry (Colorimetric), Total ProteinClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964960000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964960000VITROS CHEMISTRY PRODUCTS UPRO SLIDESJohnson & Johnson Clinical Diagnostics, Inc.1997-02-18JGP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750000637PackageGS1100In Commercial Distribution
10758750000630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000063720758750000637
1075875000063010758750000630

GMDN Terms#

Term, Definition table
TermDefinition
Total protein IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of total protein in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
623873044
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
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
06971674868040BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGP2023-07-24
06971674868392BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGP2023-07-24
06971674869252BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGP2023-07-24
06971674869269BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGP2023-07-24
06971674869276BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGP2023-07-24
06971674869283BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGP2023-07-24
06971674869290BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JGP2023-07-24
10758750000623VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JGP2020-05-29
00852169008294ClearChem Diagnostics Inc. MicroProtein, TotalCLEARCHEM DIAGNOSTICS INC.JGP2018-06-08
00817274021897JAS DiagnosticsDREW SCIENTIFIC, INC.JGP2016-09-12
00811727011916Pointe Scientific, Inc. MicroproteinHORIBA INSTRUMENTS INCORPORATEDJGP2016-08-31
00811727011923Pointe Scientific, Inc. Microprotein StandardHORIBA INSTRUMENTS INCORPORATEDJGP2016-08-31
00811727012753Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDJGP2016-08-31
10758750000593VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JGP2016-08-10