Instant Test Cup 10-300

GUDID 00816555021502

COC300, OPI300, AMP1000, MET1000, BZO300, OXY100 with adulteration OX/SG/pH drugs of abuse test cup (CLIA WAIVED)

BRANAN MEDICAL CORPORATION

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Primary Device ID00816555021502
NIH Device Record Keya7f79fa7-9939-4467-af76-d8e97464e731
Commercial Distribution StatusIn Commercial Distribution
Brand NameInstant Test Cup
Version Model Number10-300
Catalog Number10-300
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 Perscriptionfalse
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
GS100816555021502 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJGEnzyme Immunoassay, Opiates

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 Date2016-09-01

On-Brand Devices [Instant Test Cup]

00816555021502COC300, OPI300, AMP1000, MET1000, BZO300, OXY100 with adulteration OX/SG/pH drugs of abuse test
00816555021496COC300, OPI300, AMP1000, MET1000, PCP25, MDMA500, BAR300, BZO300, MTD300, TCA1000, OXY100 with a
00816555021489THC50, COC300, OPI300, AMP1000, MET1000, PCP25, MDMA500, BAR300, BZO300, MTD300, TCA1000, OXY100
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