EZ-hCG Urine Pregnancy Test

GUDID 08305901048253

The EZ-hCGTM Urine test is a one-step immunoassay for the rapid, qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy.

BIOMERICA, INC.

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID08305901048253
NIH Device Record Key1b8b2d95-04f1-42e5-9717-1897eb369706
Commercial Distribution Discontinuation2020-07-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEZ-hCG Urine Pregnancy Test
Version Model Number1048-25
Company DUNS067647321
Company NameBIOMERICA, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108305901048253 [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 Number4
Public Version Date2021-09-02
Device Publish Date2016-12-08

On-Brand Devices [EZ-hCG Urine Pregnancy Test]

00083059104851The EZ-hCGTM Urine test is a one-step immunoassay for the rapid, qualitative determination of hu
08305901048253The EZ-hCGTM Urine test is a one-step immunoassay for the rapid, qualitative determination of hu
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