Alltest Pregnancy Rapid Test

GUDID 06936983155151

1T, FDA OTC, Without Absorbent wick

Hangzhou AllTest Biotech Co., Ltd.

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Primary Device ID06936983155151
NIH Device Record Keyed310cc0-9a4d-4cd4-a542-02e4cd9af9ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlltest Pregnancy Rapid Test
Version Model Number1
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
GS106936983155151 [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 Date2024-09-09
Device Publish Date2024-08-31

On-Brand Devices [Alltest Pregnancy Rapid Test]

069369831551511T, FDA OTC, Without Absorbent wick
069369831551441T, FDA OTC

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