DrugCheck 60622

GUDID B298606220

DrugCheck NxStep OnSite Drug Test CLIA Waived - AMP BZO COC OPI PCP THC

Express Diagnostic Int'l, Inc.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device IDB298606220
NIH Device Record Key6d0d6ef9-a2e7-4079-8e18-004951201503
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrugCheck
Version Model Number60622
Catalog Number60622
Company DUNS015875273
Company NameExpress Diagnostic 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

Phone(626) 443-8480
Emailqa-ra@whpm.com
Phone(626) 443-8480
Emailqa-ra@whpm.com
Phone(626) 443-8480
Emailqa-ra@whpm.com
Phone(626) 443-8480
Emailqa-ra@whpm.com
Phone(626) 443-8480
Emailqa-ra@whpm.com
Phone(626) 443-8480
Emailqa-ra@whpm.com
Phone(626) 443-8480
Emailqa-ra@whpm.com
Phone(626) 443-8480
Emailqa-ra@whpm.com
Phone(626) 443-8480
Emailqa-ra@whpm.com
Phone(626) 443-8480
Emailqa-ra@whpm.com
Phone(626) 443-8480
Emailqa-ra@whpm.com
Phone(626) 443-8480
Emailqa-ra@whpm.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB298606220 [Primary]

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-17
Device Publish Date2025-12-09