VITROS 6177752

GUDID 20758750034915

VITROS Immunodiagnostic Products CA 19-9 Calibrators

ORTHO CLINICAL DIAGNOSTICS

Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
Primary Device ID20758750034915
NIH Device Record Key7cc24de4-e888-4d83-9fa3-f0d2364bf96f
Commercial Distribution StatusIn Commercial Distribution
Brand NameVITROS
Version Model Number6177752
Catalog Number6177752
Company DUNS215865786
Company NameORTHO CLINICAL DIAGNOSTICS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored frozen, no more than 1 freeze-thaw cycle
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored frozen, no more than 1 freeze-thaw cycle
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored frozen, no more than 1 freeze-thaw cycle
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored frozen, no more than 1 freeze-thaw cycle
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored frozen, no more than 1 freeze-thaw cycle
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored frozen, no more than 1 freeze-thaw cycle
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored frozen, no more than 1 freeze-thaw cycle
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored frozen, no more than 1 freeze-thaw cycle
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored frozen, no more than 1 freeze-thaw cycle
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored frozen, no more than 1 freeze-thaw cycle
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *May be stored frozen, no more than 1 freeze-thaw cycle

Device Identifiers

Device Issuing AgencyDevice ID
GS110758750034918 [Primary]
GS120758750034915 [Package]
Contains: 10758750034918
Package: Case [30 Units]
In Commercial Distribution

FDA Product Code

JITCalibrator, secondary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-03
Device Publish Date2024-04-25

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10758750008322VITROS Immunodiagnostic Products RE Controls
10758750002528VITROS Immunodiagnostic Products Troponin I ES Range Verifiers

Trademark Results [VITROS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VITROS
VITROS
87764891 5492323 Live/Registered
Crimson U.S. Assets LLC
2018-01-22
VITROS
VITROS
87202232 5204885 Live/Registered
Crimson U.S. Assets LLC
2016-10-13
VITROS
VITROS
75142862 2126793 Live/Registered
CRIMSON U.S. ASSETS LLC
1996-07-31
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