FDA.reportPublic FDA data

VITROS

Primary DI
10758750008735
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
1290709
Catalog number
1290709
Device description
VITROS Chemistry Products Calibrator Kit 3
Published
2016-08-23
Public version status
Update
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
JIXCALIBRATOR, MULTI-ANALYTE MIXTURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750008732PackageGS130In Commercial Distribution
10758750008735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875000873220758750008732
1075875000873510758750008735

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry enzyme IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative detection of multiple clinical chemistry enzymes. Analytes detected may include alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-18 Degrees Celsius-18 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

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Primary DI, Brand, Company table
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05430003908662SEEKER®Lacar MDX TechnologiesJIX2026-01-15
05430003908679SEEKER®Lacar MDX TechnologiesJIX2026-01-15
04250317554994Plasma Calibrator SetChromsystems Instruments + Chemicals GmbHJIX2025-07-31
07613336232156Ionify CalSet Steroids and Vitamin DRoche Diagnostics GmbHJIX2025-06-25
00850053916267IDG/SanzayIDG/SANZAY CorporationJIX2024-07-03
08430793040761Aptiva® APS IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2024-03-11
08430793040907Aptiva® APS IgM CalibratorsINOVA DIAGNOSTICS, INC.JIX2024-03-11
00630414304915Atellica CH Prot2 CALSiemens Healthcare Diagnostics Inc.JIX2024-02-02
04580262010314Calibrator 2TOKYO BOEKI MEDISYS INC.JIX2023-12-18
08430793040181Aptiva® CTD Essential CalibratorsINOVA DIAGNOSTICS, INC.JIX2023-12-14
00816776020544MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
00816776020568MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
00816776020582MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
00816776020599MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
10852676007060Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JIX2023-08-09
00811403011087CO2 Alkaline BufferDiamond Diagnostics Inc.JIX2023-06-05
00816776020247MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2022-12-22
00817302024494CAROLINA LIQUID CHEMISTRIES CORP.® ISE CALIBRATOR 1 DT908CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2022-08-19
00817302024500CAROLINA LIQUID CHEMISTRIES CORP.® ISE CALIBRATOR 2 DT909CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2022-08-19
00817302024517CAROLINA LIQUID CHEMISTRIES CORP.® ISE SELECTIVITY CHECK DT910CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2022-08-19
00380740164973ARCHITECTABBOTT IRELANDJIX2022-07-12
00380740164980AlinityABBOTT IRELANDJIX2022-07-12
04250317551115Urine Calibrator SetChromsystems Instruments + Chemicals GmbHJIX2022-07-08
04250317552365Saliva Calibrator SetChromsystems Instruments + Chemicals GmbHJIX2022-06-21
00816776020513MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2022-04-05
00816776020537MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2022-04-05