Pregnancy (hCG) Rapid Test Midstream FHC-103H

GUDID 06970277512404

Pregnancy (hCG) Rapid Test Midstream

Hangzhou AllTest Biotech Co., Ltd.

Total human chorionic gonadotropin (HCG) IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)
Primary Device ID06970277512404
NIH Device Record Keye0937480-b883-406f-bc4c-35e54b8a35a4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePregnancy (hCG) Rapid Test Midstream
Version Model NumberFHC-103H
Catalog NumberFHC-103H
Company DUNS543254717
Company NameHangzhou AllTest Biotech 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
GS106970277512404 [Primary]

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 Date2018-10-08
Device Publish Date2018-09-05

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