DOA 4 PANEL TEST 07RD7063-02

GUDID 00817830021033

Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / COC / OPI / THC

RAPID DIAGNOSTICS INC

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00817830021033
NIH Device Record Key21c1722a-f51c-4bdb-b1ee-8c52e1116e37
Commercial Distribution StatusIn Commercial Distribution
Brand NameDOA 4 PANEL TEST
Version Model Number07RD7063-02
Catalog Number07RD7063-02
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
GS100817830021033 [Primary]

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

On-Brand Devices [DOA 4 PANEL TEST]

00817830021231Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / M-A
00817830021224Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / MTD
00817830021217Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC / OPI
00817830021200Immunoassay for the detection of the following drug substance(s) in human urine: BZD / BUP / OPI
00817830021194Immunoassay for the detection of the following drug substance(s) in human urine: BZD / BUP / OPI
00817830021187Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC
00817830021170Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC
00817830021163Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC
00817830021156Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC
00817830021149Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / OPI
00817830021132Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / OPI
00817830021125Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / M-A
00817830021118Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / M-A
00817830021101Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / MTD
00817830021095Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / MTD
00817830021088Immunoassay for the detection of the following drug substance(s) in human urine: BZD / MTD / OPI
00817830021071Immunoassay for the detection of the following drug substance(s) in human urine: BZD / MTD / OPI
00817830021064Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD
00817830021057Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD
00817830021040Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / COC / O
00817830021033Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / COC / O
00817830021026Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI
00817830021019Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI
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