DrugCheck 30195C

GUDID B29830195C0

Single Dip Cassette Drug Test, PPX

EXPRESS DIAGNOSTICS INT'L, INC.

Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, immunochromatographic test (ICT), rapid Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
Primary Device IDB29830195C0
NIH Device Record Key9f71b2ac-7e42-4a54-bd6a-8f1c83f7fd91
Commercial Distribution Discontinuation2019-04-26
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDrugCheck
Version Model Number30195C
Catalog Number30195C
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
HIBCCB29830195C0 [Primary]

FDA Product Code

JXNEnzyme Immunoassay, Propoxyphene

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 Date2016-10-18