Pregnancy Check hCG Strip

GUDID 00852108007135

ALLSOURCE SCREENING SOLUTIONS, LLC

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00852108007135
NIH Device Record Keybc31564a-5d0e-4b3f-ab58-14177403a094
Commercial Distribution StatusIn Commercial Distribution
Brand NamePregnancy Check hCG Strip
Version Model NumberALLHCGSR
Company DUNS080358180
Company NameALLSOURCE SCREENING SOLUTIONS, LLC
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100852108007135 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-22

On-Brand Devices [Pregnancy Check hCG Strip]

00852108007135ALLHCGSR
00852108007128ALLHCGSR
00852108007111ALLHCGSR

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