DIGIVAL

GUDID 00811877010623

DIGIVAL is a small bench top instrument to be used in conjunction with Alere™ rapid tests.

Alere Scarborough, Inc.

Photometric immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD Photometric/spectroscopic immunoassay analyser IVD
Primary Device ID00811877010623
NIH Device Record Key5ba2b0d8-d8da-4d9b-82c1-473df590f79a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIGIVAL
Version Model NumberEQ00600X
Company DUNS154148498
Company NameAlere Scarborough, Inc.
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811877010623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-16
Device Publish Date2019-07-08

Devices Manufactured by Alere Scarborough, Inc.

10811877010545 - Alere NMP22 Test2023-09-14 For the in vitro quantitative measurement of the Nuclear Matrix Protein NMP22 in stabilized urine (ELISA).
10811877010606 - Alere NMP22 BladderChek Control Kit 2023-09-14 The Alere NMP22 BladderChek Control Kit consists of a Negative and a Positive Control solution for use as an external control fo
10811877010637 - Alere NMP22® Urine Collection Kit 2023-09-14 The Alere NMP22® Urine Collection Kit is intended for the collection, stabilization, and transport of human urine which will b
10811877010798 - DIGIVAL Calibration Check Card Pack2023-09-14 A calibration check card verifies that the DIGIVAL is functioning correctly
00811877011477 - BinaxNOW COVID-19 Antigen Self Test2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
00811877011507 - BinaxNOW COVID-19 Antigen Self Test2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
00811877011798 - BinaxNOW COVID-19 Antigen Self Test2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
10811877010019 - Alere i Influenza A & B 22023-09-12 A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimen

Trademark Results [DIGIVAL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DIGIVAL
DIGIVAL
88070857 not registered Live/Pending
Alere Scarborough, Inc.
2018-08-08
DIGIVAL
DIGIVAL
88070855 not registered Live/Pending
Alere Scarborough, Inc.
2018-08-08
DIGIVAL
DIGIVAL
88070852 not registered Live/Pending
Alere Scarborough, Inc.
2018-08-08

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