BluRapids™ TNR CDOA7125A3

GUDID 00850011007112

BluRapids CLIA Waived Drug Cup; 13 Panel AMP,BAR,BZO,COC,MET,MDMA,OPI300,MTD,OXY,PCP,TCA,THC with 3 AD (+pH, OX,SG)

MERCEDES MEDICAL, LLC

Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00850011007112
NIH Device Record Keya315ba17-2627-4d86-96d7-674c771ba104
Commercial Distribution StatusIn Commercial Distribution
Brand NameBluRapids™
Version Model NumberTNR CDOA7125A3
Catalog NumberTNR CDOA7125A3
Company DUNS834472680
Company NameMERCEDES MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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-Counterfalse

Customer Support Contacts

Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com
Phone8003312716
Emailsherry.harris@mercedesmedical.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from direct sunlight,moisture, and heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Handling Environment TemperatureBetween 40 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850011007112 [Primary]
GS110850011007119 [Package]
Package: Inner pack [25 Units]
In Commercial Distribution
GS120850011007116 [Package]
Contains: 10850011007119
Package: Case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDJEnzyme Immunoassay, Cannabinoids

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 Date2016-08-15

On-Brand Devices [BluRapids™]

00850011007112BluRapids CLIA Waived Drug Cup; 13 Panel AMP,BAR,BZO,COC,MET,MDMA,OPI300,MTD,OXY,PCP,TCA,THC wit
00850011007105BluRapids CLIA Waived Drug Cup; 13 Panel AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA/TH
00850011007099BluRapids CLIA Waived Drug Cup; 12 Panel BluRapids AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/
00850011007082BluRapids CLIA Waived Drug Cup; 12 Panel AMP/BAR/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA/THC
00850011007075BluRapids CLIA Waived Drug Cup; 12 Panel AMP/BAR/BUP/BZO/COC/MTD/MDMA/MET/OPI2000/OXY/PCP/THC ;
00850011007068BluRapids CLIA Waived Drug Cup; 12 panel AMP/ BAR/BUP/BZO/COC/MDMA/MET/MTD/OPI-300/OXY/ PCP/THC
00850011007044BluRapids CLIA Waived Drug Cup; 6 Panel with Adulterants BZO/COC/MET/OPI/OXY/THC
20850011007031BlueRapids CLIA Waived Drug Cup; 6 Panel AMP/BZO/COC/MET/OPI2000/THC
10850011007027BlueRapids CLIA Waived Drug Cup; 5-Panal AMP/COC/PCP/OPI2000/THC
20850011007017BluRapids CLIA Waived Drug Cup; 5-Panel AMP/COC/MET/OPI/THC

Trademark Results [BluRapids]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BLURAPIDS
BLURAPIDS
86725382 5087815 Live/Registered
MERCEDES MEDICAL, LLC
2015-08-14

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