DrugCheck 30163C

GUDID B29830163C0

Single Dip Cassette Drug Test, OPI300

EXPRESS DIAGNOSTICS INT'L, INC.

Opiate/opiate metabolite IVD, kit, immunochromatographic test (ICT) Opiate/opiate metabolite IVD, kit, immunochromatographic test (ICT) Opiate/opiate metabolite IVD, kit, rapid ICT, clinical Opiate/opiate metabolite IVD, kit, rapid ICT, clinical Opiate/opiate metabolite IVD, kit, rapid ICT, clinical Opiate/opiate metabolite IVD, kit, rapid ICT, clinical Opiate/opiate metabolite IVD, kit, rapid ICT, clinical Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
Primary Device IDB29830163C0
NIH Device Record Key076d21ec-3c1b-4578-b4ce-cf2f46aa87a1
Commercial Distribution Discontinuation2019-04-26
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDrugCheck
Version Model Number30163C
Catalog Number30163C
Company DUNS168560402
Company NameEXPRESS DIAGNOSTICS INT'L, INC.
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-Counterfalse

Customer Support Contacts

Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com
Phone507-526-3951
Emailquality@drugcheck.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB29830163C0 [Primary]

FDA Product Code

DJGEnzyme Immunoassay, Opiates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-05-02
Device Publish Date2016-08-29