FDA.reportPublic FDA data

INCUP

Primary DI
10694644400721
Brand
INCUP
Company
AMERICAN BIO MEDICA CORPORATION
Model
10-7SPC-283
Catalog number
10-7SPC-283
Device description
InCup with THC/OPI300/METH/BZO/MDMA/COC/BAR
Published
2020-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LAGHigh Pressure Liquid Chromatography, Methamphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LAGHigh Pressure Liquid Chromatography, MethamphetamineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073078000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073078000RAPID TOX CUPAmerican Bio Medica Corp.2008-05-30LAG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10694644400721PrimaryGS10
10694644450726Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1069464440072110694644400721
1069464445072610694644450726

GMDN Terms#

Term, Definition table
TermDefinition
Multiple therapeutic drugs/drugs of abuse IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple therapeutic drugs and drugs of abuse in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Regulatory Flags#

DUNS number
966665036
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10694644700036Easy Lab Pro RSV10-RSV-ELP10-RSV-ELP2023-01-12
10694644100355Rapid TOX10-METT-000 10-METT-000 2016-09-23
10694644800019Rapid ONE10-METS-000 10-METS-000 2016-09-23
10694644300793RDS 10-7SPB-25510-7SPB-2552021-07-22
10694644350798RDS 10-7SPB-25510-7SPB-2552021-07-22
10694644400745INCUP10-5SPCA-38610-5SPCA-3862021-06-24
10694644450740INCUP10-5SPCA-38610-5SPCA-3862021-06-24
10694644300786RDS10-4SP1-00910-4SP1-0092021-06-10
10694644350781RDS10-4SP1-00910-4SP1-0092021-06-10
10694644300779RDS10-7SP-30710-7SP-3072021-05-28
10694644400738INCUP10-6SC-03010-6SC-0302020-09-17
10694644450733INCUP10-6SC-03010-6SC-0302020-09-17
10694644450726INCUP10-7SPC-28310-7SPC-2832020-08-13
10694644100454Rapid TOX10-5ZT-200 10-5ZT-2002020-05-29
10694644150459Rapid TOX10-5ZT-200 10-5ZT-2002020-05-29
10694644100010Rapid TOX10-10BPXT-030 10-10BPXT-030 2016-09-23
10694644100027Rapid TOX10-10BPXT-200 10-10BPXT-200 2016-09-23
10694644100034Rapid TOX10-10XT-030 10-10XT-030 2016-09-23
10694644100041Rapid TOX10-10XT-200 10-10XT-200 2016-09-23
10694644100058Rapid TOX10-10XTA3-030 10-10XTA3-030 2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONLAG2021-06-24
10694644400738INCUPAMERICAN BIO MEDICA CORPORATIONLAG2020-09-17
10694644450733INCUPAMERICAN BIO MEDICA CORPORATIONLAG2020-09-17
10694644450726INCUPAMERICAN BIO MEDICA CORPORATIONLAG2020-08-13
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLAG2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLAG2019-09-28
10694644400714INCUPAMERICAN BIO MEDICA CORPORATIONLAG2019-03-11
10694644400707INCUPAMERICAN BIO MEDICA CORPORATIONLAG2018-10-29
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLAG2018-05-23
10694644400691INCUPAMERICAN BIO MEDICA CORPORATIONLAG2018-04-20
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLAG2018-04-19
10694644400684INCUPAMERICAN BIO MEDICA CORPORATIONLAG2018-02-16
10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLAG2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLAG2017-10-12
10694644400677INCUPAMERICAN BIO MEDICA CORPORATIONLAG2017-10-10
10694644500254RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLAG2017-08-02
10694644200444RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLAG2017-06-29
10694644500247RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLAG2017-05-31
10694644400660INCUPAMERICAN BIO MEDICA CORPORATIONLAG2017-05-05
10694644500230RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLAG2017-04-25
10694644400653INCUPAMERICAN BIO MEDICA CORPORATIONLAG2017-03-21
10694644500216RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLAG2017-03-13
10694644500223RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLAG2017-03-13
10694644500193RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLAG2017-01-12
10694644500209RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLAG2017-01-12
10694644400646INCUPAMERICAN BIO MEDICA CORPORATIONLAG2016-12-08
10694644500186RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLAG2016-11-29
10694644400639INCUPAMERICAN BIO MEDICA CORPORATIONLAG2016-11-15
10694644500179RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONLAG2016-11-02
10694644200437RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLAG2016-10-10