DOA POSITIVE CONTROL

GUDID 00695684400026

Positive Control for Drugs of Abuse Tests

GERMAINE LABORATORIES, INC

Multiple therapeutic drugs/drugs of abuse IVD, control Multiple therapeutic drugs/drugs of abuse IVD, control
Primary Device ID00695684400026
NIH Device Record Keyf79db8f3-8c0e-4f89-ae60-bdde1108a48c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDOA POSITIVE CONTROL
Version Model Number40002
Company DUNS176458115
Company NameGERMAINE LABORATORIES, 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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100695684400026 [Primary]

FDA Product Code

DIFDrug Mixture Control Materials

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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