DOA 3 PANEL TEST 07RD7062-02

GUDID 00817830020784

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

RAPID DIAGNOSTICS INC

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID00817830020784
NIH Device Record Key31034cb7-b535-4396-81e9-be14a6653d20
Commercial Distribution StatusIn Commercial Distribution
Brand NameDOA 3 PANEL TEST
Version Model Number07RD7062-02
Catalog Number07RD7062-02
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
GS100817830020784 [Primary]

FDA Product Code

DIOENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES

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 3 PANEL TEST]

00817830021002Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-A
00817830020999Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / THC
00817830020982Immunoassay for the detection of the following drug substance(s) in human urine: BUP / OPI-II /
00817830020975Immunoassay for the detection of the following drug substance(s) in human urine: BUP / OPI / THC
00817830020968Immunoassay for the detection of the following drug substance(s) in human urine: AMP / OPI / THC
00817830020951Immunoassay for the detection of the following drug substance(s) in human urine: COC / MTD / OPI
00817830020944Immunoassay for the detection of the following drug substance(s) in human urine: COC / MTD / OPI
00817830020937Immunoassay for the detection of the following drug substance(s) in human urine: BUP / MTD / OPI
00817830020920Immunoassay for the detection of the following drug substance(s) in human urine: BUP / MTD / OPI
00817830020913Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / OPI
00817830020906Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / OPI
00817830020890Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / M-A
00817830020883Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / MTD
00817830020876Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / THC
00817830020869Immunoassay for the detection of the following drug substance(s) in human urine: BZD / MTD / OPI
00817830020852Immunoassay for the detection of the following drug substance(s) in human urine: BZD / MTD / OPI
00817830020845Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / OPI
00817830020838Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / OPI
00817830020821Immunoassay for the detection of the following drug substance(s) in human urine: COC / OPI-II /
00817830020814Immunoassay for the detection of the following drug substance(s) in human urine: COC / OPI / THC
00817830020807Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / OPI-II
00817830020791Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / OPI / T
00817830020784Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / T
00817830020777Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / THC
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.