NEW CHOICE PLUS

GUDID 00667742001117

ONE STEP PREGNANCY TEST

SCI Medic, Inc.

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00667742001117
NIH Device Record Key05dce266-c033-461a-b21a-b22158d8f661
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEW CHOICE PLUS
Version Model Number00111
Company DUNS117568595
Company NameSCI Medic, 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 Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100667742001117 [Primary]

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 Date2022-05-13
Device Publish Date2022-05-05

On-Brand Devices [NEW CHOICE PLUS]

00667742001117ONE STEP PREGNANCY TEST
00677421001116New Choice Plus One Step Pregnancy Test

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