FDA.reportPublic FDA data

THC Rapid Test Cassette

Primary DI
00853691007168
Brand
THC Rapid Test Cassette
Company
ACRO BIOTECH INC
Model
1
Device description
THC 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
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853691007168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853691007168008536910071688536910071680853691007168

GMDN Terms#

Term, Definition table
TermDefinition
Cannabinoid IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cannabinoids in a clinical specimen, using an enzyme immunoassay (EIA) method.

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
00853691007151OPI 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

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Primary DI, Brand, Company table
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10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10722066005139Rapid ResponseBTNX IncLDJ2020-06-03
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2020-05-29
10763924935632Accutest JANT PHARMACAL CORPORATIONLDJ2019-03-05
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10694644300694RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-03-23
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10694644500377RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLDJ2018-03-14
10694644500384RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLDJ2018-03-14
10694644300687RDSAMERICAN BIO MEDICA CORPORATIONLDJ2018-02-13
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.LDJ2017-11-15
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