Pregmate Pregnancy Test Strips (50 Count)

GUDID 00850009763167

Pregmate LLC

Total human chorionic gonadotropin (HCG) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00850009763167
NIH Device Record Key97d3aada-baa3-4f74-b492-b4a54366ae4f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePregmate Pregnancy Test Strips (50 Count)
Version Model Number50HCG
Company DUNS071197287
Company NamePregmate LLC
Device Count50
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 Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850009763167 [Primary]
GS100850009763259 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCXKit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-11
Device Publish Date2023-04-03

On-Brand Devices [Pregmate Pregnancy Test Strips (50 Count)]

0085000976316750HCG
00850009763259100HCG

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