FDA.reportPublic FDA data

RDS

Primary DI
10694644300649
Brand
RDS
Company
AMERICAN BIO MEDICA CORPORATION
Model
10-5ZS-200
Catalog number
10-5ZS-200
Device description
5w/BZO, Opi 2K BULK PACK 50
Published
2017-04-06
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
DISEnzyme Immunoassay, Barbiturate
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
LCMEnzyme Immunoassay, Phencyclidine
LDJEnzyme Immunoassay, Cannabinoids
LFIHigh Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2
LFIHigh Pressure Liquid Chromatography, Tricyclic Antidepressant DrugsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002447000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002447000MODIFICATION TO RAPID DRUG SCREEN 9-PANELAmerican Bio Medica Corp.2000-11-16DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10694644300649PrimaryGS10
10694644350644Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1069464430064910694644300649
1069464435064410694644350644

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
50
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
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJC2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.LDJ2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.JXM2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DIO2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DJG2017-11-15
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONLCM2016-09-23
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONLDJ2016-09-23
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2016-09-23
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJC2016-09-23