FDA.reportPublic FDA data

Monitect Drug Screen Cassette Test

Primary DI
00816555020024
Brand
Monitect Drug Screen Cassette Test
Company
BRANAN MEDICAL CORPORATION
Model
MC13
Catalog number
MC13
Device description
OPI300 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
DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.Clinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816555020024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816555020024008165550200248165550200240816555020024

GMDN Terms#

Term, Definition table
TermDefinition
Morphine/morphine metabolite 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 morphine and/or morphine metabolites 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
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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10796918002010INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, MOR300, THCALFA SCIENTIFIC DESIGNS, INC.DOE2018-12-14
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10796918001938INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)ALFA SCIENTIFIC DESIGNS, INC.DOE2018-08-28
10796918001945INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)ALFA SCIENTIFIC DESIGNS, INC.DOE2018-08-28
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