Arvolife

GUDID 10851950008045

50 Ovulation Tests and 20 Pregnancy Tests Comb Kit

Clinical Guard

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10851950008045
NIH Device Record Key5252634e-6561-4bda-90b8-b96d0856e887
Commercial Distribution StatusIn Commercial Distribution
Brand NameArvolife
Version Model NumberFertility Kit
Company DUNS827033924
Company NameClinical Guard
Device Count70
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
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
GS100851950008048 [Primary]
GS100851950008109 [Unit of Use]
GS110851950008045 [Package]
Contains: 00851950008048
Package: [60 Units]
In Commercial Distribution

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 Date2018-04-27
Device Publish Date2018-03-27

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1085195000804550 Ovulation Tests and 20 Pregnancy Tests Comb Kit

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