FDA.report

DOA 5 PANEL TEST

Primary DI
00817830021248
Brand
DOA 5 PANEL TEST
Company
RAPID DIAGNOSTICS INC
Model
07RD7064-01
Catalog number
07RD7064-01
Device description
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI / PCP / THC
Published
2016-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DKZENZYME IMMUNOASSAY, AMPHETAMINE

Product Code Classifications

CodeDeviceSpecialtyClass
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817830021248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817830021248008178300212488178300212480817830021248

GMDN Terms

TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Device Sizes

TypeValueUnit
Length75Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)854-0530custserv@mpbio.com

Regulatory Flags

DUNS number
008028248
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00817830020029RAPID DIAGNOSTICS M-AMPHAMPHETAMINE TEST STRIP07RD700507RD70052016-10-20
00817830020036RAPID DIAGNOSTICS COCAINE TEST STRIP07RD700707RD70072016-10-20
00817830020050RAPID DIAGNOSTICS OPIATES TEST STRIP07RD701107RD70112016-10-20
00817830020074RAPID DIAGNOSTICS BARBITURATE TEST STRIP07RD701507RD70152016-10-20
00817830020081RAPID DIAGNOSTICS BENZODIAZEPINE TEST STRIP07RD701707RD70172016-10-20
00817830020098RAPID DIAGNOSTICS METHADONE TEST STRIP07RD701907RD70192016-10-20
00817830020104RAPID DIAGNOSTICS PCP TEST STRIP07RD702107RD70212016-10-20
00817830020111RAPID DIAGNOSTICS OPI/MOR TEST STRIP - 200007RD703907RD70392016-10-20
00817830020135RAPID DIAGNOSTICS BUPRENORPHINE TEST STRIP07RD710507RD71052016-10-20
00817830020142RAPID DIAGNOSTICS M-AMPHAMPHETAMINE TEST STRIP KIT (50)07RD800507RD80052016-10-24
00817830020159RAPID DIAGNOSTICS COCAINE TEST STRIP KIT (50)07RD800707RD80072016-10-24
00817830020166RAPID DIAGNOSTICS MARIJUANA (THC) TEST STRIP KIT (50)07RD800907RD80092016-10-20
00817830020173RAPID DIAGNOSTICS OPIATES TEST STRIP KIT (50)07RD801107RD80112016-10-24
00817830020180RAPID DIAGNOSTICS AMPHETAMINE TEST STRIP KIT (50)07RD801307RD80132016-10-20
00817830020197RAPID DIAGNOSTICS BARBITURATE TEST STRIP KIT (50)07RD801507RD80152016-10-24
00817830020203RAPID DIAGNOSTICS BENZODIAZEPINE TEST STRIP KIT (50)07RD801707RD80172016-10-24
00817830020210RAPID DIAGNOSTICS METHADONE TEST STRIP KIT (50)07RD801907RD80192016-10-24
00817830020227RAPID DIAGNOSTICS PCP TEST STRIP KIT (50)07RD802107RD80212016-10-24
00817830020234RAPID DIAGNOSTICS OPI/MOR 2000 TEST STRIP KIT (50)07RD803907RD80392016-10-24
00817830020241RAPID DIAGNOSTICS OXYCODONE TEST STRIP KIT (50)07RD810007RD81002016-10-20

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