FDA.reportPublic FDA data

Fastect II Drug Screen Dipstick Test

Primary DI
00816555021069
Brand
Fastect II Drug Screen Dipstick Test
Company
BRANAN MEDICAL CORPORATION
Model
MF22
Catalog number
MF22
Device description
MDMA500 single drug dipstick test
Published
2016-08-01
Public version status
Update
Distribution status
Not 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
DKZEnzyme Immunoassay, Amphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040203000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040203000MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22Branan Medical Corp.2004-03-25DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816555021069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816555021069008165550210698165550210690816555021069

GMDN Terms#

Term, Definition table
TermDefinition
Amphetamine/methamphetamine group IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of the amphetamine and/or methamphetamine group(s) [e.g., 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy] in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-468-3287info@brananmedical.com

Regulatory Flags#

DUNS number
184347305
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816555020031Monitect Drug Screen Cassette TestMC14MC142016-08-01
00816555020048Monitect Drug Screen Cassette TestMC15MC152016-08-01
00816555020055Monitect Drug Screen Cassette TestMC16MC162016-08-01
00816555020116Monitect Drug Screen Cassette TestMC22MC222016-08-01
00816555020161Monitect Drug Screen Cassette TestBC28BC282016-08-01
00816555020994Fastect II Drug Screen Dipstick TestMF14MF142016-08-01
00816555021007Fastect II Drug Screen Dipstick TestMF16MF162016-08-01
00816555020000Monitect Drug Screen Cassette TestMC10MC102016-08-01
00816555020963Fastect II Drug Screen Dipstick TestMF10MF102016-08-01
00816555020017Monitect Drug Screen Cassette TestMC11MC112016-08-01
00816555020024Monitect Drug Screen Cassette TestMC13MC132016-08-01
00816555020062Monitect Drug Screen Cassette TestMC17MC172016-08-01
00816555020079Monitect Drug Screen Cassette TestMC18MC182016-08-01
00816555020086Monitect Drug Screen Cassette TestMC19MC192016-08-01
00816555020093Monitect Drug Screen Cassette TestMC20MC202016-08-01
00816555020109Monitect Drug Screen Cassette TestMC21MC212016-08-01
00816555020123Monitect Drug Screen Cassette TestMC23MC232016-08-01
00816555020130Monitect Drug Screen Cassette TestBC10BC102016-08-01
00816555020154Monitect Drug Screen Cassette TestBC17SBC17S2016-08-01
00816555020178Monitect Drug Screen Cassette TestTC11TC112016-08-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035547Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035561Identify HealthMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10722066005290Rapid Response Multi-Drug Integrated Split Spec. CupBTNX IncDKZ2023-04-28
10694644400745INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2021-06-24
10694644300779RDSAMERICAN BIO MEDICA CORPORATIONDKZ2021-05-28
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10694644200505RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2019-10-03
10694644200499RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2019-09-28
10694644400714INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2019-03-11
10694644500407RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-12-05
10694644400707INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2018-10-29
10694644500391RTCII 2nd gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-06-20
10694644200482RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-05-23
10722355002573Detector Drug CupImmunostics Company, IncDKZ2018-05-21
10722355002580Detector Drug CupImmunostics Company, IncDKZ2018-05-21
10694644400691INCUPAMERICAN BIO MEDICA CORPORATIONDKZ2018-04-20
10694644200475RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDKZ2018-04-19
10694644300724RDSAMERICAN BIO MEDICA CORPORATIONDKZ2018-04-19
10694644300700RDSAMERICAN BIO MEDICA CORPORATIONDKZ2018-03-23
10694644300717RDSAMERICAN BIO MEDICA CORPORATIONDKZ2018-03-23