AdexusDx hCG Test 8001-1

GUDID 00858022006193

Box of one test cartridge

NOWDIAGNOSTICS, INC.

Human chorionic gonadotropin beta-core fragment (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical Human chorionic gonadotropin beta-core fragment IVD, kit, rapid ICT, clinical
Primary Device ID00858022006193
NIH Device Record Key43a9dcae-a9f7-46d4-9ac5-804e13c1e234
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdexusDx hCG Test
Version Model Number8001-1
Catalog Number8001-1
Company DUNS079541513
Company NameNOWDIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Customer Support Contacts

Phone(479) 966-4511
Emailduane.poorman@nowdx.com
Phone(479) 966-4511
Emailduane.poorman@nowdx.com
Phone(479) 966-4511
Emailduane.poorman@nowdx.com
Phone(479) 966-4511
Emailduane.poorman@nowdx.com
Phone(479) 966-4511
Emailduane.poorman@nowdx.com
Phone(479) 966-4511
Emailduane.poorman@nowdx.com
Phone(479) 966-4511
Emailduane.poorman@nowdx.com
Phone(479) 966-4511
Emailduane.poorman@nowdx.com
Phone(479) 966-4511
Emailduane.poorman@nowdx.com
Phone(479) 966-4511
Emailduane.poorman@nowdx.com
Phone(479) 966-4511
Emailduane.poorman@nowdx.com
Phone(479) 966-4511
Emailduane.poorman@nowdx.com
Phone(479) 966-4511
Emailduane.poorman@nowdx.com
Phone(479) 966-4511
Emailduane.poorman@nowdx.com
Phone(479) 966-4511
Emailduane.poorman@nowdx.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858022006193 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JHIVisual, Pregnancy Hcg, Prescription Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-12-22

On-Brand Devices [AdexusDx hCG Test]

00858022006216Box of 50 cartridges/tests
00858022006209Box of 25 cartridges/tests
00858022006193Box of one test cartridge

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