FDA.reportPublic FDA data

INCUP

Primary DI
10694644450726
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
OTC
false
Sterile
false
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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
966665036
Device count
25
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

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
10694644400721INCUP10-7SPC-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
10694644400721INCUPAMERICAN 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