FDA.reportPublic FDA data

RDS

Primary DI
10694644350798
Brand
RDS
Company
AMERICAN BIO MEDICA CORPORATION
Model
10-7SPB-255
Catalog number
10-7SPB-255
Device description
OX,BUP,BZ,Meth,MTD,COC,OP3 BULK
Published
2021-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFIHigh Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
10694644300793PrimaryGS10
10694644350798Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1069464430079310694644300793
1069464435079810694644350798

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
966665036
Device count
50
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
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
10694644100058Rapid TOX10-10XTA3-030 10-10XTA3-030 2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10694644300793RDSAMERICAN BIO MEDICA CORPORATIONLFI2021-07-22
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONLFI2021-06-24
10694644300786RDSAMERICAN BIO MEDICA CORPORATIONLFI2021-06-10
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONLFI2021-05-28
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLFI2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLFI2019-09-28
10694644400714INCUPAMERICAN BIO MEDICA CORPORATIONLFI2019-03-11
10694644300762RDSAMERICAN BIO MEDICA CORPORATIONLFI2019-02-13
10694644400707INCUPAMERICAN BIO MEDICA CORPORATIONLFI2018-10-29
10694644300755RDSAMERICAN BIO MEDICA CORPORATIONLFI2018-09-14
10694644300748RDSAMERICAN BIO MEDICA CORPORATIONLFI2018-07-05
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLFI2018-05-23
10694644300731RDSAMERICAN BIO MEDICA CORPORATIONLFI2018-05-23
10694644400691INCUPAMERICAN BIO MEDICA CORPORATIONLFI2018-04-20
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLFI2018-04-19
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONLFI2018-04-19
10694644300694RDSAMERICAN BIO MEDICA CORPORATIONLFI2018-03-23
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONLFI2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONLFI2018-03-23
10694644400684INCUPAMERICAN BIO MEDICA CORPORATIONLFI2018-02-16
10694644300687RDSAMERICAN BIO MEDICA CORPORATIONLFI2018-02-13
10694644200468RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLFI2017-10-18
10694644200451RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLFI2017-10-12
10694644400677INCUPAMERICAN BIO MEDICA CORPORATIONLFI2017-10-10
10694644200444RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLFI2017-06-29
10694644300663RDSAMERICAN BIO MEDICA CORPORATIONLFI2017-06-08
10694644300670RDSAMERICAN BIO MEDICA CORPORATIONLFI2017-06-08
10694644400660INCUPAMERICAN BIO MEDICA CORPORATIONLFI2017-05-05
10694644300649RDSAMERICAN BIO MEDICA CORPORATIONLFI2017-04-06
10694644300656RDSAMERICAN BIO MEDICA CORPORATIONLFI2017-04-06