DTPM

GUDID 16970429841342

Co-Innovation Biotech Co., Ltd

Amphetamine-specific IVD, kit, rapid ICT, clinical
Primary Device ID16970429841342
NIH Device Record Keyae45a749-a205-45a3-b313-a006af2d1b0e
Commercial Distribution Discontinuation2023-12-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDTPM
Version Model Number13P
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 Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106970429841345 [Primary]
GS116970429841342 [Package]
Contains: 06970429841345
Package: [25 Units]
Discontinued: 2023-11-10
Not in Commercial Distribution
GS126970429841349 [Package]
Contains: 06970429841345
Package: [100 Units]
Discontinued: 2023-11-10
Not in Commercial Distribution
GS136970429841346 [Package]
Contains: 06970429841345
Package: [210 Units]
Discontinued: 2023-11-10
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DISEnzyme Immunoassay, Barbiturate

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-18
Device Publish Date2023-12-08

On-Brand Devices [DTPM]

1697042984163216P
1697042984134213P

Trademark Results [DTPM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DTPM
DTPM
90550637 not registered Live/Pending
DTPM, Inc.
2021-02-27

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