Mosie Baby Pregnancy Test

GUDID 00695684957018

Urine Midstream, Rapid qualitative test to detect the presence of hCG in urine. Designed for self testing (home). Results within 3 minutes.

GERMAINE LABORATORIES, INC

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00695684957018
NIH Device Record Key4c784b67-3799-497c-bd75-bd4470229bb5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMosie Baby Pregnancy Test
Version Model Number95701
Company DUNS176458115
Company NameGERMAINE LABORATORIES, INC
Device Count2
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 Datetrue
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
GS100695684891039 [Unit of Use]
GS100695684957018 [Primary]

FDA Product Code

DHASystem, Test, Human Chorionic Gonadotropin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-31
Device Publish Date2019-10-21

On-Brand Devices [Mosie Baby Pregnancy Test]

06956848940166Urine Midstream, Rapid qualitative test to detect the presence of hCG in urine. Designed for se
00695684957018Urine Midstream, Rapid qualitative test to detect the presence of hCG in urine. Designed for se

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