FDA.reportPublic FDA data

OPI Rapid Test Cassette

Primary DI
00853691007151
Brand
OPI Rapid Test Cassette
Company
ACRO BIOTECH INC
Model
1
Device description
OPI Rapid Test Cassette
Published
2017-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00853691007151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853691007151008536910071518536910071510853691007151

GMDN Terms#

Term, Definition table
TermDefinition
Morphine/morphine metabolite 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 morphine and/or morphine metabolites 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079697380
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853691007205Pregnancy (hCG) Urine/Serum Combo Rapid Test Cassette1FHC-2022017-04-01
00853691007229hCG Enhanced Sensitivity Rapid Test Cassette 10 mIU/mL12017-07-06
00853691007670hCG Rapid Test Cassette 25 mIU/mL12017-07-03
00853691007687hCG Rapid Test Midstream 25 mIU/mL12017-07-03
00853691007694hCG Enhanced Sensitivity Rapid Test Midstream 10 mIU/mL12017-07-06
00853691007168THC Rapid Test Cassette12017-06-28
00853691007113AMP Rapid Test Cassette12017-06-28
00853691007120BZO Rapid Test Cassette12017-06-28
00853691007137COC Rapid Test Cassette12017-06-28
00853691007595FOB Rapid Test Cassette12017-03-17
00853691007649MET Rapid Test Cassette12017-06-28
00853691007656PCP Rapid Test Cassette12017-06-28
00853691007663MDMA Rapid Test Cassette12017-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-03-23
10694644300687RDSAMERICAN BIO MEDICA CORPORATIONDJG2018-02-13
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DJG2017-11-15
10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2017-10-12
10694644200444RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2017-06-29
10694644300663RDSAMERICAN BIO MEDICA CORPORATIONDJG2017-06-08
10694644300670RDSAMERICAN BIO MEDICA CORPORATIONDJG2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2017-06-08
10694644300649RDSAMERICAN BIO MEDICA CORPORATIONDJG2017-04-06