SAFECUP III MULTIDRUG 10

GUDID 00695684401054

GERMAINE LABORATORIES, INC

Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT)
Primary Device ID00695684401054
NIH Device Record Key09885af6-44fa-48da-879c-29d2b35fc4fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAFECUP III MULTIDRUG 10
Version Model Number40105
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
GS100695684401051 [Unit of Use]
GS100695684401054 [Primary]

FDA Product Code

DJREnzyme Immunoassay, Methadone

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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