AmediCheck Instant Test Cup C-C0611A-3A

GUDID 00816555020277

COC, OPI300, AMP, MET, OXY, BZO with Adulteration Screen for OX/SG/PH

BRANAN MEDICAL CORPORATION

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00816555020277
NIH Device Record Keyf5636229-e1b0-4b78-9342-fd5a82a1badc
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmediCheck Instant Test Cup
Version Model NumberC-C0611A-3A
Catalog NumberC-C0611A-3A
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-Countertrue

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
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 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816555020277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2018-07-06
Device Publish Date2016-08-01

On-Brand Devices [AmediCheck Instant Test Cup]

00816555021472THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MTD, TCA, OXY
00816555020314THC, COC, OPI, AMP, PCP with Adulteration Screen for OX/SG/PH
00816555020307THC, COC, OPI, MET, PCP with Adulteration Screen for OX/SG/PH
00816555020291THC, COC, OPI, AMP, MET with Adulteration Screen for OX/SG/PH
00816555020284THC, COC, OPI, AMP, MET, PCP25 with Adulteration Screen for OX/SG/PH
00816555020277COC, OPI300, AMP, MET, OXY, BZO with Adulteration Screen for OX/SG/PH
00816555020260THC, COC, OPI, AMP, MET, MDMA, BAR, BZO, MTD, OXY with Adulteration Screen for OX/SG/PH
00816555020253THC, COC, OPI300, AMP, MET, MDMA, BAR, BZO, MTD, OXY
00816555020246COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY
00816555020239THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY
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