FDA.reportPublic FDA data

VITROS

Primary DI
10758750006922
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
6801744
Catalog number
6801744
Device description
VITROS Chemistry Products Protein Performance Verifier I
Published
2020-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JITCalibrator, secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10758750006922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075875000692210758750006922

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry protein IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry proteins 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10758750035656VITROS627222262722222025-05-21
10758750005345ORTHO9337309337302025-02-17
10758750005031VITROS856804085680402016-08-10
10758750005352ORTHO934090F934090F2016-08-24
10758750030149ORTHO690463069046302016-08-24
10758750000067VITROS179235717923572020-06-06
10758750000388VITROS198821119882112016-08-23
10758750000593VITROS680012068001202016-08-10
10758750000616VITROS680018968001892016-08-23
10758750001354VITROS680176768017672016-08-26
10758750001743VITROS680198868019882016-08-10
10758750001750VITROS680198968019892016-08-23
10758750001774VITROS680199168019912016-08-23
10758750001811VITROS680199568019952016-08-23
10758750001828VITROS680199668019962016-08-26
10758750001835VITROS680199768019972016-08-26
10758750001842VITROS680199868019982016-08-26
10758750002283VITROS680221468022142016-08-26
10758750002290VITROS680221668022162016-08-23
10758750002535VITROS680230468023042016-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336222331ISE Internal Standard Gen.2 conc.Roche Diagnostics GmbHJIT2026-03-20
04015630926091Testosterone II CalSet IIRoche Diagnostics GmbHJIT2026-02-23
04560189213418ST AIA-PACK PROG II CALIBRATOR SETTOSOH CORPORATIONJIT2026-02-02
00817089023222DiazymeDIAZYME LABORATORIES, INC.JIT2026-01-21
04562185403060HbA1c Calibrator Set (S)TOSOH CORPORATIONJIT2026-01-05
00380740189822AlinityAbbott GmbHJIT2026-01-01
00380740189846ARCHITECTAbbott GmbHJIT2026-01-01
00380740168742AlinityAbbott Ireland DiagnosticsJIT2025-12-11
07613336216958CalSet Phospho-Tau (181P) PlasmaRoche Diagnostics GmbHJIT2025-11-18
24560189216338CL AIA-PACK Prolactin II ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24560189216635CL AIA-PACK hs-E2 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24562185395451CL AIA-PACK T3 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24562185399671CL AIA-PACK Progesterone ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24562185399725CL AIA-PACK LH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24562185400407CL AIA-PACK FSH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
05711435000163ProNephro AKI™ (NGAL) Calibrator KitBioporto Diagnostics A/SJIT2025-08-28
00630414320304Atellica CH UAlb CALSiemens Healthcare Diagnostics Inc.JIT2025-08-11
07613336180822CalSet Cortisol III UrineRoche Diagnostics GmbHJIT2025-07-24
15099590763633Access Syphilis CalibratorsBeckman Coulter, Inc.JIT2025-05-07
04987595300011PATHFAST Sample Diluent 1PHC CORPORATIONJIT2025-04-18
04987595300028PATHFAST Sample Diluent 2PHC CORPORATIONJIT2025-04-18
04015630924288sFlT-1 CalSetRoche Diagnostics GmbHJIT2025-04-07
04015630925407CalSet PlGFRoche Diagnostics GmbHJIT2025-04-07
05055845400534Alere NT-proBNP for Alinity Calibrator KitAXIS-SHIELD DIAGNOSTICS LIMITEDJIT2025-02-27
08058056685285ACE CalibratorSENTINEL CH. SPAJIT2025-01-27
08058056685315ACE CalibratorSENTINEL CH. SPAJIT2025-01-27
20758750034625VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
20758750035066VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
08430793243001HEMOSIL RIVAROXABAN CALIBRATORSINSTRUMENTATION LABORATORY COMPANYJIT2024-07-22
20758750034915VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-04-25