FDA.reportPublic FDA data

DrugCheck

Primary DI
B29830111C0
Brand
DrugCheck
Company
EXPRESS DIAGNOSTICS INT'L, INC.
Model
30111C
Catalog number
30111C
Device description
Single Dip Cassette Drug Test, OXY
Published
2016-08-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DJGEnzyme Immunoassay, Opiates

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B29830111C0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Oxycodone 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 oxycodone 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
507-526-3951quality@drugcheck.com

Regulatory Flags#

DUNS number
168560402
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B29830140C0DrugCheck30140C30140C2016-08-29
B298605000DrugCheck60500605002016-08-31
B298610200DrugCheck61020610202016-09-02
B298304180DrugCheck30418304182016-08-29
B298608200DrugCheck60820608202016-09-01
B298611240DrugCheck61124611242017-09-11
B298301100DrugCheck30110301102016-08-31
B29830110C0DrugCheck30110C30110C2016-08-29
B298301900DrugCheck30190301902016-08-29
B29830190C0DrugCheck30190C30190C2016-08-29
B298301400DrugCheck30140301402016-08-29
B298409000AlcoCheck40900409002017-02-20
B29850700DC0DrugCheck50700-DC50700-DC2019-03-29
B29850900DC0DrugCheck50900-DC50900-DC2019-03-29
B298301000DrugCheck30100301002016-09-12
B29830100C0DrugCheck30100C30100C2016-08-29
B298301110DrugCheck30111301112016-08-31
B298301200DrugCheck30120301202016-08-31
B29830120C0DrugCheck30120C30120C2016-08-29
B298301250DrugCheck30125301252016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJG2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONDJG2021-07-22
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONDJG2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDJG2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2020-05-29
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2019-09-28
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONDJG2019-02-13
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2019-02-12
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-07-05
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2018-05-23
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-05-23
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2018-04-19
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-04-19
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2018-03-30
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-03-23