FDA.reportPublic FDA data

Monitect Drug Screen Cassette Test

Primary DI
00816555020062
Brand
Monitect Drug Screen Cassette Test
Company
BRANAN MEDICAL CORPORATION
Model
MC17
Catalog number
MC17
Device description
PCP25 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
LCMEnzyme Immunoassay, Phencyclidine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCMEnzyme Immunoassay, PhencyclidineUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816555020062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816555020062008165550200628165550200620816555020062

GMDN Terms#

Term, Definition table
TermDefinition
Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT)A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of phencyclidine (PCP) in a clinical specimen, using an immunochromatographic test (ICT) method.

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
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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