SAFECUP II MULTIDRUG N5

GUDID 00695684454555

Lateral flow immunoassay for the detection of drugs of abuse in urine. Flat-side cup for easy photocopying. Tests for COC, AMP, THC, OPI, PCP (cocaine, amphetamine, marijuana, opiates, Phencyclidine).

GERMAINE LABORATORIES, INC

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Primary Device ID00695684454555
NIH Device Record Key251b345e-5471-4c5f-a06a-730168116349
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAFECUP II MULTIDRUG N5
Version Model Number45455
Company DUNS176458115
Company NameGERMAINE LABORATORIES, INC
Device Count25
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100695684454551 [Unit of Use]
GS100695684454555 [Primary]

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 Date2018-03-29
Device Publish Date2016-05-12

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