Fastect II Drug Screen Dipstick Test MF22

GUDID 00816555021069

MDMA500 single drug dipstick test

BRANAN MEDICAL CORPORATION

Amphetamine/methamphetamine group IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00816555021069
NIH Device Record Keyf21fd8d7-3090-4050-984c-d123623eec53
Commercial Distribution StatusIn Commercial Distribution
Brand NameFastect II Drug Screen Dipstick Test
Version Model NumberMF22
Catalog NumberMF22
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
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
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
GS100816555021069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-08
Device Publish Date2016-08-01

On-Brand Devices [Fastect II Drug Screen Dipstick Test]

00816555021250THC50/COC300/MET500/MDMA500 multiple drugs dipstick test
00816555021243BZO300/COC300/OPI300/MTD300 multiple drugs dipstick test
00816555021236THC50/COC300/OPI300/MET500 multiple drugs dipstick test
00816555021229THC50/COC300/OPI300/MTD300 multiple drugs dipstick test
00816555021212THC50/COC300/OPI300/BZO300 multiple drugs dipstick test
00816555021205BZO300/BAR300/MTD300/OXY100 multiple drugs dipstick test
00816555021199THC50/AMP1000/OPI300 multiple drugs dipstick test
00816555021182THC50/COC300/OXY100 multiple drugs dipstick test
00816555021175THC50/COC300/MET500 multiple drugs dipstick test
00816555021168COC300/OPI300/MET500 multiple drugs dipstick test
00816555021151THC50/COC300/OPI300 multiple drugs dipstick test
00816555021144THC50/OPI300/MET500 multiple drugs dipstick test
00816555021137THC50/MDMA500 multiple drugs dipstick test
00816555021120THC50/OPI300 multiple drugs dipstick test
00816555021113THC50/MET500 multiple drugs dipstick test
00816555021090THC50/COC300 multiple drugs dipstick test
00816555021083BUP10 single drug dipstick test
00816555021076OXY100 single drug dipstick test
00816555021069MDMA500 single drug dipstick test
00816555021052TCA1000 single drug dipstick test
00816555021045MTD300 single drug dipstick test
00816555021038BAR300 single drug dipstick test
00816555021021BZO300 single drug dipstick test
00816555021014PCP25 single drug dipstick test
00816555021007MET500 single drug dipstick test
00816555020994AMP1000 single drug dipstick test
00816555020987OPI300 single drug dipstick test
00816555020970COC300 single drug dipstick test
00816555020963THC50 single drug dipstick test
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