MP DOA-5 TEST CUP 07RD7111-07

GUDID 00817830020388

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

RAPID DIAGNOSTICS INC

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00817830020388
NIH Device Record Key13a60422-1fc9-47b7-bf60-011052b5715e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMP DOA-5 TEST CUP
Version Model Number07RD7111-07
Catalog Number07RD7111-07
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

Height74 Millimeter
Height74 Millimeter
Height74 Millimeter
Height74 Millimeter
Height74 Millimeter
Height74 Millimeter
Height74 Millimeter
Height74 Millimeter
Height74 Millimeter
Height74 Millimeter
Height74 Millimeter
Height74 Millimeter
Height74 Millimeter
Height74 Millimeter
Height74 Millimeter
Height74 Millimeter
Height74 Millimeter
Height74 Millimeter
Height74 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
GS100817830020388 [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 [MP DOA-5 TEST CUP]

00817830020432Immunoassay for the detection of the following drug substance(s) in human urine: BAR / BZD / COC
00817830020425Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / MTD
00817830020418Immunoassay for the detection of the following drug substance(s) in human urine: BUP / COC / MTD
00817830020401Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC
00817830020395Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD
00817830020388Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC
00817830020371Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI
00817830020364Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC
00817830020357Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-A
00817830020340Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-A
00817830020333Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / M-A
00817830020326Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / O
00817830020319Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.