equate 6 Days Sooner Pregnancy Test Strip

GUDID 20045611473618

equate 6 Days Sooner Pregnancy Test Strip, 50T/Bag

Guangzhou Decheng Biotechnology Co., LTD

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Primary Device ID20045611473618
NIH Device Record Keyb8064f58-c1d0-4df4-9830-4d1462da3a74
Commercial Distribution StatusIn Commercial Distribution
Brand Nameequate 6 Days Sooner Pregnancy Test Strip
Version Model Number50T
Company DUNS554534314
Company NameGuangzhou Decheng Biotechnology Co., LTD
Device Count50
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 Datetrue
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
GS120045611473618 [Primary]
GS150045611473619 [Unit of Use]

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 Date2025-05-20
Device Publish Date2025-05-12

Devices Manufactured by Guangzhou Decheng Biotechnology Co., LTD

50045611010005 - SURESIGN™ Pregnancy Rapid Test2026-02-05 5ct 25mIU - Single Step Pregnancy Test
50045611010012 - SURESIGN™ Early Detection Pregnancy Test2026-02-05 5ct 10mIU - 6 Day Early Pregnancy Test
50045611010029 - SURESIGN™ Digital Pregnancy Rapid Test2026-02-05 3ct 25mIU - Digital Pregnancy Test
50045611010036 - SURESIGN™ Early Detection Pregnancy Test + Digital Pregancy Rapid Test2026-02-05 1ct 10mIU Early Detection Pregnancy Test +1ct 25mIU Digital Pregancy Rapid Test
50045611010043 - SURESIGN™ Ovulation & Pregnancy Rapid Tests2026-02-05 10ct Ovulation Rapid Test Midstream + 1ct 25mIU Pregnancy Rapid Test
50045611010050 - SURESIGN™ Menopause (FSH) Rapid Test2026-02-05 2ct Menopause (FSH) Rapid Test
50045611010074 - SURESIGN™ Digital Ovulation Rapid Test2026-02-05 1ct Digital Ovulation Rapid Test Holder + 20ct Digital Ovulation Rapid Test Stick
30011822020283 - RITE AID2025-09-08 RITE AID Pregnancy Test Strips, 50T/Bag

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