FIRSTVIEW hCG Urine Test Strip HCG-1011

GUDID 06974246460833

Safecare Biotech (Hangzhou) Co., Ltd.

Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing
Primary Device ID06974246460833
NIH Device Record Key447f71b8-e1be-42a9-93e3-bdddcd0c360b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIRSTVIEW hCG Urine Test Strip
Version Model NumberHCG-1011
Catalog NumberHCG-1011
Company DUNS544349634
Company NameSafecare Biotech (Hangzhou) Co., Ltd.
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
GS106974246460833 [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 Date2023-09-13
Device Publish Date2023-09-05

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