AICARE

GUDID 26970429840120

HCG Pregnancy Test Strip

Co-Innovation Biotech Co., Ltd

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID26970429840120
NIH Device Record Key74e63f49-8282-4294-bcd5-1fc948d6aded
Commercial Distribution Discontinuation2019-03-18
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAICARE
Version Model NumberHCG Pregnancy Test
Company DUNS421302978
Company NameCo-Innovation 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
GS106970429840126 [Primary]
GS126970429840120 [Package]
Contains: 06970429840126
Package: [22 Units]
Discontinued: 2019-03-18
Not in Commercial Distribution
GS136970429840127 [Package]
Contains: 06970429840126
Package: [10 Units]
Discontinued: 2019-03-18
Not 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 Date2019-03-26
Device Publish Date2019-03-18

On-Brand Devices [AICARE]

26970429843114THC Screen Test Dipcard
06970429840577Multi Drug Screen Test Dipcard
26970429840120HCG Pregnancy Test Strip

Trademark Results [AICARE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AICARE
AICARE
97834176 not registered Live/Pending
WU, SHIYI
2023-03-10
AICARE
AICARE
88880639 not registered Live/Pending
Shenzhen ShuangPingTai Medical Technology Co., Ltd.
2020-04-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.