Monitect Drug Screen Cassette Test MC18

GUDID 00816555020079

BZO300 Cassette Tests

BRANAN MEDICAL CORPORATION

Benzodiazepine group IVD, kit, immunochromatographic test (ICT), rapid Benzodiazepine group IVD, kit, immunochromatographic test (ICT), rapid Benzodiazepine group IVD, kit, immunochromatographic test (ICT), rapid Benzodiazepine group IVD, kit, rapid ICT, clinical Benzodiazepine group IVD, kit, rapid ICT, clinical Benzodiazepine group IVD, kit, rapid ICT, clinical Benzodiazepine group IVD, kit, rapid ICT, clinical Benzodiazepine group IVD, kit, rapid ICT, clinical Benzodiazepine group IVD, kit, rapid ICT, clinical Benzodiazepine group IVD, kit, rapid ICT, clinical
Primary Device ID00816555020079
NIH Device Record Key772bbfc1-ac09-4536-a2dc-6fc1e48bfcb0
Commercial Distribution Discontinuation2018-11-02
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMonitect Drug Screen Cassette Test
Version Model NumberMC18
Catalog NumberMC18
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816555020079 [Primary]

FDA Product Code

JXMEnzyme Immunoassay, Benzodiazepine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-05
Device Publish Date2016-08-01

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