DOA 1 PANEL TEST 07RD7060-11

GUDID 00817830020760

Immunoassay for the detection of the following drug substance(s) in human urine: BUP

RAPID DIAGNOSTICS INC

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Primary Device ID00817830020760
NIH Device Record Key438640da-90f9-48b2-ab6c-925192d37627
Commercial Distribution StatusIn Commercial Distribution
Brand NameDOA 1 PANEL TEST
Version Model Number07RD7060-11
Catalog Number07RD7060-11
Company DUNS008028248
Company NameRAPID DIAGNOSTICS INC
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com
Phone+1(800)854-0530
Emailcustserv@mpbio.com

Device Dimensions

Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter
Length75 Millimeter

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817830020760 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2016-10-20

On-Brand Devices [DOA 1 PANEL TEST]

00817830020760Immunoassay for the detection of the following drug substance(s) in human urine: BUP
00817830020753Immunoassay for the detection of the following drug substance(s) in human urine: THC
00817830020746Immunoassay for the detection of the following drug substance(s) in human urine: PCP
00817830020739Immunoassay for the detection of the following drug substance(s) in human urine: OXY
00817830020722Immunoassay for the detection of the following drug substance(s) in human urine: OPI-II
00817830020715Immunoassay for the detection of the following drug substance(s) in human urine: OPI
00817830020708Immunoassay for the detection of the following drug substance(s) in human urine: MTD
00817830020692Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP
00817830020685Immunoassay for the detection of the following drug substance(s) in human urine: COC
00817830020678Immunoassay for the detection of the following drug substance(s) in human urine: BZD
00817830020661Immunoassay for the detection of the following drug substance(s) in human urine: BAR
00817830020654Immunoassay for the detection of the following drug substance(s) in human urine: AMP
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