CYTO-STAT /COULTER CLONE 3A1-RD1/T11-FITC 6604239

GUDID 15099590540135

CYTO-STAT /COULTER CLONE 3A1-RD1/T11-FITC (Analyte Specific Reagent)

Beckman Coulter, Inc.

Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody Multiple CD cell marker IVD, antibody
Primary Device ID15099590540135
NIH Device Record Key9292cd9d-bef6-48a8-b87a-3c1ac49d8a07
Commercial Distribution StatusIn Commercial Distribution
Brand NameCYTO-STAT /COULTER CLONE 3A1-RD1/T11-FITC
Version Model Number6604239
Catalog Number6604239
Company DUNS008254708
Company NameBeckman Coulter, Inc.
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

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590540135 [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 Date2020-09-08
Device Publish Date2020-08-31

Devices Manufactured by Beckman Coulter, Inc.

15099590575243 - Access hLH2024-05-01 The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing
15099590760823 - Access NT-proBNP2024-04-29 The Access NT-proBNP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of N-term
15099590760830 - ACCESS NT-proBNP CALIBRATORS2024-04-29 The Access NT-proBNP Calibrators are intended to calibrate the Access NT-proBNP assay for the quantitative determination of N-te
15099590772840 - Access Ferritin2024-04-15 The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferriti
15099590745158 - ACCESS HIV Ag/Ab combo2024-03-25 The Access HIV Ag/Ab combo assay is a paramagnetic particle, chemiluminescent immunoassay for the simultaneous qualitative in vi
15099590745165 - ACCESS HIV Ag/Ab combo Calibrators2024-03-25 The Access HIV Ag/Ab combo Calibrators are intended to calibrate the Access HIV Ag/Ab combo assay for the simultaneous qualitati
15099590745172 - ACCESS HIV Ag/Ab combo QC2024-03-25 The Access HIV Ag/Ab combo QC is intended for monitoring system performance of the Access HIV Ag/Ab combo assay. The Access HIV
15099590793005 - MicroScan2024-03-25 DVD, LabPro V4_V5 Maintenance Update 05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.