FDA.reportPublic FDA data

RTCII 1st gen.

Primary DI
10694644200086
Brand
RTCII 1st gen.
Company
AMERICAN BIO MEDICA CORPORATION
Model
10-6MZX2B-030
Catalog number
10-6MZX2B-030
Device description
6RpToxCup2/Met,Bzo op3 -200/bx
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
DKEReagents, Test, Tetrahydrocannabinol
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
JXNEnzyme Immunoassay, Propoxyphene
LAGHigh Pressure Liquid Chromatography, Methamphetamine
LCMEnzyme Immunoassay, Phencyclidine
LFIHigh Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
DKEReagents, Test, TetrahydrocannabinolClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
JXNEnzyme Immunoassay, PropoxypheneClinical Toxicology2
LAGHigh Pressure Liquid Chromatography, MethamphetamineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LFIHigh Pressure Liquid Chromatography, Tricyclic Antidepressant DrugsClinical 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
10694644200086PrimaryGS10
10694644250081Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1069464420008610694644200086
1069464425008110694644250081

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
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
518-758-8158customerservice@abmc.com

Regulatory Flags#

DUNS number
966665036
Device count
200
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
10694644400721INCUP10-7SPC-28310-7SPC-2832020-08-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894175000091QMedix™Diagnostic Automation, Inc.LCM2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.DJG2026-09-30
00894175000091QMedix™Diagnostic Automation, Inc.DIO2026-09-30
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyJXN2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyLCM2026-09-28
00810173657556Healgen ScientificHealgen Scientific Limited Liability CompanyDJR2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyLCM2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDJR2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyJXN2026-09-28
00810173657686Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDJR2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyLCM2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173657693Healgen ScientificHealgen Scientific Limited Liability CompanyJXN2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyJXN2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDKZ2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDIO2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDJG2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyJXM2026-09-28
00810173658102Healgen ScientificHealgen Scientific Limited Liability CompanyDJR2026-09-28