PREGABLE

GUDID 16970429840161

HCG TEST

Co-Innovation Biotech Co., Ltd

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID16970429840161
NIH Device Record Key1c7c0b51-e7c0-4cde-90f2-ac1ab9f8e84d
Commercial Distribution Discontinuation2021-06-11
Commercial Distribution StatusIn Commercial Distribution
Brand NamePREGABLE
Version Model Number1
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 Kittrue
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
GS106970429840164 [Primary]
GS116970429840161 [Package]
Contains: 06970429840164
Package: [3 Units]
Discontinued: 2021-06-11
In Commercial Distribution
GS126970429840168 [Package]
Contains: 06970429840164
Package: [20 Units]
Discontinued: 2021-06-11
In Commercial Distribution
GS136970429840165 [Package]
Contains: 06970429840164
Package: [10 Units]
Discontinued: 2021-06-11
In Commercial Distribution
GS146970429840162 [Package]
Contains: 06970429840164
Package: [30 Units]
Discontinued: 2021-06-11
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 Date2021-06-10
Device Publish Date2021-06-02

Devices Manufactured by Co-Innovation Biotech Co., Ltd

16970429843414 - co-innovation2025-05-27
16970429843315 - co-innovation2024-08-28
16970429841342 - DTPM2023-12-18
16970429841632 - DTPM2023-12-18
16970429840154 - HCG TEST STRIP2023-07-06
16970429840178 - co-innovation2023-05-08
16970429841816 - co-innovation2022-11-21 Rapid Multi-drug Test Cup
16970429841441 - co-innovation2022-01-24 14P Drug Test

Trademark Results [PREGABLE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PREGABLE
PREGABLE
90693426 not registered Live/Pending
SMILELAB. CO.,LTD.
2021-05-06
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