HCG TEST STRIP

GUDID 16970429840154

Co-Innovation Biotech Co., Ltd

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Primary Device ID16970429840154
NIH Device Record Key745c8bc7-c3c3-4c90-a17c-a6be3ba6200f
Commercial Distribution Discontinuation2019-12-26
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHCG TEST STRIP
Version Model NumberHCG3.5
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
GS106970429840157 [Primary]
GS116970429840154 [Package]
Contains: 06970429840157
Package: [100 Units]
Discontinued: 2019-12-26
Not in Commercial Distribution
GS126970429840151 [Package]
Package: [100 Units]
Discontinued: 2019-12-26
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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-07-06
Device Publish Date2019-12-25

Devices Manufactured by Co-Innovation Biotech Co., Ltd

16970429843315 - co-innovation2024-08-28
16970429841342 - DTPM2023-12-18
16970429841632 - DTPM2023-12-18
16970429840154 - HCG TEST STRIP2023-07-06
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
16970429841533 - co-innovation2022-01-24 15P Drug Test

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