FDA.reportPublic FDA data

Monitect Drug Screen Cassette Test

Primary DI
00816555020109
Brand
Monitect Drug Screen Cassette Test
Company
BRANAN MEDICAL CORPORATION
Model
MC21
Catalog number
MC21
Device description
TCA1000 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
MLKThin Layer Chroomatography, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLKThin Layer Chromatography, Tricyclic Antidepressant DrugsClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816555020109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816555020109008165550201098165550201090816555020109

GMDN Terms#

Term, Definition table
TermDefinition
Tricyclic antidepressant IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of tricyclic antidepressant drugs 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.

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
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
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
00096295140583LEADERCardinal Health 110, Inc.MLK2021-06-11
10743816001539Status DS™ TCA cardPRINCETON BIOMEDITECH CORPORATIONMLK2020-01-08
30014613337867TriageQUIDEL CARDIOVASCULAR INC.MLK2018-11-01
30014613337874TriageQUIDEL CARDIOVASCULAR INC.MLK2018-11-01
30014613337881TriageQUIDEL CARDIOVASCULAR INC.MLK2018-11-01
30014613337904TriageQUIDEL CARDIOVASCULAR INC.MLK2018-11-01
10743816000204AccuSign® TCA cardPRINCETON BIOMEDITECH CORPORATIONMLK2016-09-23
10743816000211AccuSign® TCA cardPRINCETON BIOMEDITECH CORPORATIONMLK2016-09-23
10743816000433Status DS™ 8 cardPRINCETON BIOMEDITECH CORPORATIONMLK2016-09-23
10743816000440Status DS™ 8 cardPRINCETON BIOMEDITECH CORPORATIONMLK2016-09-23
10743816000457AccuSign® DOA 8 cardPRINCETON BIOMEDITECH CORPORATIONMLK2016-09-23
10743816000464Status DS™ 9 cardPRINCETON BIOMEDITECH CORPORATIONMLK2016-09-23
10743816000471Status DS™ 9 cardPRINCETON BIOMEDITECH CORPORATIONMLK2016-09-23
10743816000488Status DS™ 10 cardPRINCETON BIOMEDITECH CORPORATIONMLK2016-09-23
10743816000501Status DS™ 10 cardPRINCETON BIOMEDITECH CORPORATIONMLK2016-09-23
10743816000518AccuSign® DOA 10 cardPRINCETON BIOMEDITECH CORPORATIONMLK2016-09-23
10743816000525StatusFirst™ 10 cardPRINCETON BIOMEDITECH CORPORATIONMLK2016-09-23
00899722002757Alere Triage®Alere San Diego, Inc.MLK2016-09-21
00899722002771Alere Triage®Alere San Diego, Inc.MLK2016-09-20
00899722002764Alere Triage®Alere San Diego, Inc.MLK2016-09-20
00893038002135Alere Triage®Alere San Diego, Inc.MLK2016-09-19
00893038002098Alere Triage®Alere San Diego, Inc.MLK2016-09-19
00893038002104Alere Triage®Alere San Diego, Inc.MLK2016-09-19