MassARRAAY Dx 260050

GUDID 00850010566009

AGENA BIOSCIENCE, INC.

Mass spectrometry analyser IVD, automated Mass spectrometry analyser IVD, automated Mass spectrometry analyser IVD, automated Mass spectrometry analyser IVD, automated Mass spectrometry analyser IVD, automated Mass spectrometry analyser IVD, automated Mass spectrometry analyser IVD, automated Mass spectrometry analyser IVD, automated Mass spectrometry analyser IVD, automated Mass spectrometry analyser IVD, automated Mass spectrometry analyser IVD, automated Mass spectrometry analyser IVD, automated Mass spectrometry analyser IVD, automated Mass spectrometry analyser IVD, automated
Primary Device ID00850010566009
NIH Device Record Keya965e988-d956-455f-a7fe-ca6a0dfaeb9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMassARRAAY Dx
Version Model Number260050
Catalog Number260050
Company DUNS079436896
Company NameAGENA BIOSCIENCE, 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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(858)882-2725
Emailglenn.wise@agenabio.com
Phone+1(858)882-2725
Emailglenn.wise@agenabio.com
Phone+1(858)882-2725
Emailglenn.wise@agenabio.com
Phone+1(858)882-2725
Emailglenn.wise@agenabio.com
Phone+1(858)882-2725
Emailglenn.wise@agenabio.com
Phone+1(858)882-2725
Emailglenn.wise@agenabio.com
Phone+1(858)882-2725
Emailglenn.wise@agenabio.com
Phone+1(858)882-2725
Emailglenn.wise@agenabio.com
Phone+1(858)882-2725
Emailglenn.wise@agenabio.com
Phone+1(858)882-2725
Emailglenn.wise@agenabio.com
Phone+1(858)882-2725
Emailglenn.wise@agenabio.com
Phone+1(858)882-2725
Emailglenn.wise@agenabio.com
Phone+1(858)882-2725
Emailglenn.wise@agenabio.com
Phone+1(858)882-2725
Emailglenn.wise@agenabio.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850010566009 [Primary]
GS100850010566009 [Primary]
GS100850010566009 [Primary]
GS100850010566009 [Primary]
GS100850010566009 [Primary]
GS100850010566009 [Primary]
GS100850010566009 [Primary]
GS100850010566009 [Primary]
GS100850010566009 [Primary]
GS100850010566009 [Primary]
GS100850010566009 [Primary]
GS100850010566009 [Primary]
GS100850010566009 [Primary]
GS100850010566009 [Primary]

FDA Product Code

DOPMASS SPECTROMETER, CLINICAL USE
DOPMASS SPECTROMETER, CLINICAL USE
DOPMASS SPECTROMETER, CLINICAL USE
DOPMASS SPECTROMETER, CLINICAL USE
DOPMASS SPECTROMETER, CLINICAL USE
DOPMASS SPECTROMETER, CLINICAL USE
DOPMASS SPECTROMETER, CLINICAL USE
DOPMASS SPECTROMETER, CLINICAL USE
DOPMASS SPECTROMETER, CLINICAL USE
DOPMASS SPECTROMETER, CLINICAL USE
DOPMASS SPECTROMETER, CLINICAL USE
DOPMASS SPECTROMETER, CLINICAL USE
DOPMASS SPECTROMETER, CLINICAL USE
DOPMASS SPECTROMETER, CLINICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-16
Device Publish Date2020-09-08

Devices Manufactured by AGENA BIOSCIENCE, INC.

00850010566009 - MassARRAAY Dx2020-09-16
00850010566009 - MassARRAAY Dx2020-09-16
00850010566016 - CPM Dx2020-09-16
10850010566020 - SpectroChip CPM Kit (2x96)2020-09-16
10850010566037 - SpectroChip CPM Kit (10x96)2020-09-16
00850010566047 - SpectroChip Standalone Chip Only)2020-09-16
00850010566054 - MassARRAY Clean Resin 28g2020-09-16
10850010566068 - Calibrant2020-09-16

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