SureStepTM Urine Test Drug Screen Strip, Oxycodone (OXY 100)

GUDID 10810124273238

ALERE SAN DIEGO, INC.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID10810124273238
NIH Device Record Keya6f66663-8ac7-40bf-a506-9e973bd76a5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSureStepTM Urine Test Drug Screen Strip, Oxycodone (OXY 100)
Version Model NumberDOX-101-a-Sgl
Company DUNS194854949
Company NameALERE SAN DIEGO, INC.
Device Count50
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 Datetrue
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
GS100810124273231 [Primary]
GS110810124273238 [Unit of Use]

FDA Product Code

DJGEnzyme Immunoassay, Opiates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-25
Device Publish Date2023-12-15

Devices Manufactured by ALERE SAN DIEGO, INC.

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10810124273795 - CERTUM One Step Multi-Line Drug Screen EZ Split2024-10-18 ++< THC50>
10810124273801 - CERTUM One Step Multi-Line Drug Screen EZ Split2024-10-18 ++++
10810124273818 - CERTUM One Step Multi-Line Drug Screen EZ Split2024-10-18 ++< mAMP1000>++ +
10810124273825 - CERTUM One Step Multi-Line Drug Screen EZ Split2024-10-18 (AMP1000/COC300/THC50)+( mAMP1000/OPl2000/PCP25)+(BZO300/TCA1000/BAR300)+
10810124274518 - CERTUM One Step Multi-Line Drug Screen EZ Split2024-10-18 ++++
10810124273146 - SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup2024-09-25 ++++
10810124273153 - SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup2024-09-25 +++++

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