FDA.reportPublic FDA data

Monitect Drug Screen Cassette Test

Primary DI
00816555020161
Brand
Monitect Drug Screen Cassette Test
Company
BRANAN MEDICAL CORPORATION
Model
BC28
Catalog number
BC28
Device description
AMP1000/MET500 Cassette Tests
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
DJCThin Layer Chromatography, Methamphetamine
DKZEnzyme Immunoassay, Amphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816555020161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816555020161008165550201618165550201610816555020161

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
00816555020994Fastect II Drug Screen Dipstick TestMF14MF142016-08-01
00816555021007Fastect II Drug Screen Dipstick TestMF16MF162016-08-01
00816555021069Fastect II Drug Screen Dipstick TestMF22MF222016-08-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B2986080760DrugCheckExpress Diagnostic Int'l, Inc.DKZ2026-09-24
00810173656719HealgenHealgen Scientific Limited Liability CompanyDKZ2026-07-31
00841824104167ECOIIW.H.P.M. INC.DKZ2026-07-07
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDKZ2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDKZ2026-06-25
00810173656726HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656771HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656788HealgenHealgen Scientific Limited Liability CompanyDKZ2026-06-03
00810173656702AccurateHealgen Scientific Limited Liability CompanyDKZ2026-06-02
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
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
10850013035677Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035684Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035691Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
00194346667574EquateWAL-MART STORES, INC.DJC2026-04-07
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18