Detector Drug Cup

GUDID 20722355002587

A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine.

IMMUNOSTICS COMPANY, INC

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Primary Device ID20722355002587
NIH Device Record Keyad32c460-96fc-4ad3-83bc-966455f75e47
Commercial Distribution StatusIn Commercial Distribution
Brand NameDetector Drug Cup
Version Model NumberHCDOAV-4125
Company DUNS119214195
Company NameIMMUNOSTICS COMPANY, INC
Device Count25
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-Counterfalse

Customer Support Contacts

Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com
Phone+1(732)918-0770
Emailtechnical@immunostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep test cup in the package until ready for use. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep test cup in the package until ready for use. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep test cup in the package until ready for use. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep test cup in the package until ready for use. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep test cup in the package until ready for use. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep test cup in the package until ready for use. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep test cup in the package until ready for use. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep test cup in the package until ready for use. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep test cup in the package until ready for use. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep test cup in the package until ready for use. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep test cup in the package until ready for use. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep test cup in the package until ready for use. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep test cup in the package until ready for use. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep test cup in the package until ready for use. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep test cup in the package until ready for use. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep test cup in the package until ready for use. DO NOT FREEZE.
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep test cup in the package until ready for use. DO NOT FREEZE.

Device Identifiers

Device Issuing AgencyDevice ID
GS110722355002580 [Primary]
GS120722355002587 [Package]
Contains: 10722355002580
Package: Case of 4 [4 Units]
In Commercial Distribution
GS180722355002589 [Unit of Use]

FDA Product Code

LCMEnzyme immunoassay, phencyclidine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-05-24
Device Publish Date2018-05-21

On-Brand Devices [Detector Drug Cup]

20722355002587A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs a
20722355002570A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs a
20722355002563A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs a
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