SureStepTM Urine Drug Test Cassette

GUDID 10815845025180

ALERE SAN DIEGO, INC.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID10815845025180
NIH Device Record Key60bf1121-91f1-40dd-ba9e-e8bae36937dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSureStepTM Urine Drug Test Cassette
Version Model NumberDOP-102
Company DUNS194854949
Company NameALERE SAN DIEGO, INC.
Device Count40
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
GS100815845025183 [Primary]
GS110815845025180 [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

On-Brand Devices [SureStepTM Urine Drug Test Cassette]

10815845025180DOP-102
10810124273337DTH-102a
10810124273313DMD-102a
10810124273290DCO-U102a
10810124273252DAM-A102a

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