Monitect Drug Screen Cassette Test BC10

GUDID 00816555020130

THC50/COC300 Cassette Tests

BRANAN MEDICAL CORPORATION

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID00816555020130
NIH Device Record Keya39b51c6-a186-4b0c-802b-2db345a44d39
Commercial Distribution Discontinuation2016-12-10
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMonitect Drug Screen Cassette Test
Version Model NumberBC10
Catalog NumberBC10
Company DUNS184347305
Company NameBRANAN MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com
Phone1-866-468-3287
Emailinfo@brananmedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816555020130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-01

On-Brand Devices [Monitect Drug Screen Cassette Test]

00816555021397OPI2000/MET1000/THC50/COC300/PCP25 Cassette Tests with Adulteration Screen for OX-PH-CR-NI
00816555021380OPI2000/AMP1000/THC50/COC300/PCP25 Cassette Tests with Adulteration Screen for OX-PH-CR
00816555021373OPI2000/MET1000/THC50/COC300 Cassette Tests with Adulteration Screen for OX-PH-CR-NI
00816555021359MET500/THC50/COC300 Cassette Tests with Adulteration Screen for OX-PH-CR-NI
00816555021335THC50/COC300 Cassette Tests with Adulteration Screen for OX-PH-CR-NI
00816555021311MET500/BZO300/AMP1000/COC300/THC50 Cassette Tests
00816555021304OPI2000/MET1000/THC50/COC300/PCP25 Cassette Tests
00816555021298OPI2000/AMP1000/THC50/COC300/PCP25 Cassette Tests
00816555021281OPI2000/MET1000/THC50/COC300 Cassette Tests
00816555020192AMP1000/THC50/COC300 Cassette Tests
00816555020185OPI300/THC50/COC300 Cassette Tests
00816555020178MET500/THC50/COC300 Cassette Tests
00816555020161AMP1000/MET500 Cassette Tests
00816555020154BAR300/BZO300 Cassette Tests
00816555020130THC50/COC300 Cassette Tests
00816555020123OXY100 Cassette Tests
00816555020116MDMA500 Cassette Tests
00816555020109TCA1000 Cassette Tests
00816555020093MTD300 Cassette Tests
00816555020086BAR300 Cassette Tests
00816555020079BZO300 Cassette Tests
00816555020062PCP25 Cassette Tests
00816555020055MET500 Cassette Tests
00816555020048MET1000 Cassette Tests
00816555020031AMP1000 Cassette Tests
00816555020024OPI300 Cassette Tests
00816555020017COC300 Cassette Tests
00816555020000THC50 Cassette Tests
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.