11Pannel drug test cup

GUDID 06970429841123

Co-Innovation Biotech Co., Ltd

Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT)
Primary Device ID06970429841123
NIH Device Record Keyf5cda88f-c5bd-4251-9e00-8d56ed605ad9
Commercial Distribution Discontinuation2019-11-04
Commercial Distribution StatusNot in Commercial Distribution
Brand Name11Pannel drug test cup
Version Model Number11Pannel drug test cup
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 Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106970429841123 [Primary]
GS116970429841120 [Package]
Package: [25 Units]
Discontinued: 2019-11-04
Not in Commercial Distribution
GS126970429841127 [Package]
Package: [210 Units]
Discontinued: 2019-11-04
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCMEnzyme Immunoassay, Phencyclidine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-05
Device Publish Date2019-10-28

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
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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