FDA.reportPublic FDA data

VITROS

Primary DI
10758750009220
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
1513209
Catalog number
1513209
Device description
VITROS Chemistry Products PHOS Slides
Published
2020-04-18
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
CEOPhosphomolybdate (colorimetric), inorganic phosphorus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEOPhosphomolybdate (Colorimetric), Inorganic PhosphorusClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932729000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932729000KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS)Eastman Kodak Company1993-08-03CEO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750009227PackageGS130In Commercial Distribution
10758750009220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000922720758750009227
1075875000922010758750009220

GMDN Terms#

Term, Definition table
TermDefinition
Inorganic phosphate (PO43-) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of inorganic phosphate (PO43-) [phosphorus] in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Can also store at or below -18
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
00380740155643AlinityABBOTT IRELANDCEO2024-03-11
00380740155650AlinityABBOTT IRELANDCEO2024-03-11
00380740155629ARCHITECTABBOTT IRELANDCEO2024-02-26
00380740155636ARCHITECTABBOTT IRELANDCEO2024-02-26
00850053916120IDG/SanzayIDG/SANZAY CorporationCEO2024-01-12
10673486001976Teco Diagnostics Phosphorus Reagent Kit (UV Method) TC MatrixTECO DIAGNOSTICSCEO2023-11-13
10673486001945Teco Diagnostics Inorganic Phosphorus Reagent Set (Color Method)TECO DIAGNOSTICSCEO2023-11-10
10673486001969Teco Diagnostics Inorganic Phosphorus Reagent Set (UV Method)TECO DIAGNOSTICSCEO2023-11-10
06971674865056BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865070BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865087BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865100BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865117BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865124BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865131BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865148BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865155BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-22
06971674865032BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-21
06971674865049BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-21
06971674865063BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-21
06971674865094BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CEO2023-07-21
05055273204865INORGANIC PHOSPHOROUS (PHOS)RANDOX LABORATORIES LIMITEDCEO2022-10-05
00817302024197CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218CAROLINA LIQUID CHEMISTRIES CORPORATIONCEO2022-08-19
00817302024272CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT CC218CAROLINA LIQUID CHEMISTRIES CORPORATIONCEO2022-08-19
00817302024432CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT DT218CAROLINA LIQUID CHEMISTRIES CORPORATIONCEO2022-08-19
00817302024579CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT ST218CAROLINA LIQUID CHEMISTRIES CORPORATIONCEO2022-08-19
00817302024098CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT AU-218CAROLINA LIQUID CHEMISTRIES CORPORATIONCEO2022-07-06
04015630918973Phosphate (Inorganic) ver.2Roche Diagnostics GmbHCEO2021-05-27
04015630927265Phosphate ver.2Roche Diagnostics GmbHCEO2021-02-08
00811727015945Pointe Phosphorus ReagentHORIBA INSTRUMENTS INCORPORATEDCEO2021-01-30