CD19-PE-Cyanine7 CYT-19C4-A

GUDID 08436548983406

CD19-PE-Cyanine7

CYTOGNOS SL

CD19 cell marker IVD, antibody
Primary Device ID08436548983406
NIH Device Record Keyab938d03-6e6f-41cf-af56-ff612b29b985
Commercial Distribution StatusIn Commercial Distribution
Brand NameCD19-PE-Cyanine7
Version Model NumberCYT-19C4-A
Catalog NumberCYT-19C4-A
Company DUNS563942887
Company NameCYTOGNOS SL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108436548983406 [Primary]

FDA Product Code

MVUReagents, Specific, Analyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-03
Device Publish Date2022-09-23

Devices Manufactured by CYTOGNOS SL

08436548983352 - CD38-multi-epitope-FITC2022-10-03 CD38-multi-epitope-FITC
08436548983369 - CD38-FITC2022-10-03 CD38-FITC
08436548983376 - CD38-APC-C750™2022-10-03 CD38-APC-C750™
08436548983390 - CD138-PE 2022-10-03 CD138-PE
08436548983406 - CD19-PE-Cyanine7 2022-10-03CD19-PE-Cyanine7
08436548983406 - CD19-PE-Cyanine7 2022-10-03 CD19-PE-Cyanine7
08436548983437 - CD3-APC-C750™2022-10-03 CD3-APC-C750™
08436548983444 - CD45-APC-C750™2022-10-03 CD45-APC-C750™
08436548983468 - CD45-OC515™2022-10-03 CD45-OC515™

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