FDA.report

NA

Primary DI
10815845020437
Brand
NA
Company
ALERE SAN DIEGO, INC.
Model
DOX-102
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DJGEnzyme Immunoassay, Opiates

Product Code Classifications

CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10815845020437PrimaryGS10
00815845020430Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081584502043710815845020437
00815845020430008158450204308158450204300815845020430

GMDN Terms

TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Sterilization Methods

Method

Regulatory Flags

DUNS number
194854949
Device count
40
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10810124273849CERTUM One Step Multi-Drug Screen PanelDOA-154-061-a45666013262024-12-17
10810124273856CERTUM One Step Multi-Drug Screen PanelDOA-154-201-a45666113262024-12-17
10810124273863CERTUM One Step Multi-Drug Screen PanelDOA-134-011-a45666213262024-12-17
10810124273870CERTUM One Step Multi-Drug Screen PanelDOA-124-031-a45666313262024-12-17
10815845023148SureStep™ Urine Test Drug Screen StripDCO-10145605590022024-12-17
10815845023155SureStep™ Urine Test Drug Screen StripDBA-10145605690022024-12-17
10815845023162SureStep™ Urine Test Drug Screen StripDPC-10145605790022024-12-17
10815845023797SureStep™ Urine Test Drug Screen StripDTC-10145609790022024-12-17
10815845024220SureStep™ Urine Test Drug Screen StripDMD-10145610190022024-12-17
10815845024237SureStep™ Urine Test Drug Screen StripDMO-10145610290022024-12-17
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10815845024275SureStep™ Urine Test Drug Screen StripDMT-10145610690022024-12-17
10815845024299SureStep™ Urine Test Drug Screen StripDTH-10145610890022024-12-17
10815845024305SureStep™ Urine Test Drug Screen StripDBZ-10145611090022024-12-17
10815845024381SureStep™ Urine Test Drug Screen StripDAM-10145611790022024-12-17
10815845024398SureStep™ Urine Test Drug Screen StripDOP-10145611890022024-12-17
10815845024404SureStep™ Urine Test Drug Screen StripDME-10145611990022024-12-17
10810124272972CERTUM One Step Multi-Line Drug Screen EZ SplitDBO-167-022-a45651613262024-10-10

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00812101031063ARK™ Hydrocodone AssayARK DIAGNOSTICS INCDJG2024-10-16
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00812101031087ARK™ Hydrocodone AssayARK DIAGNOSTICS INCDJG2024-10-16
00812101031094ARK™ Hydrocodone CalibratorARK DIAGNOSTICS INCDJG2024-10-16
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