FDA.reportPublic FDA data

RAPID DIAGNOSTICS OPI/MOR TEST STRIP - 2000

Primary DI
00817830020111
Brand
RAPID DIAGNOSTICS OPI/MOR TEST STRIP - 2000
Company
RAPID DIAGNOSTICS INC
Model
07RD7039
Catalog number
07RD7039
Device description
OPI/MOR TEST STRIP - 2000
Published
2016-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DJGENZYME IMMUNOASSAY, OPIATES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817830020111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817830020111008178300201118178300201110817830020111

GMDN Terms#

Term, Definition table
TermDefinition
Morphine/morphine metabolite 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 morphine and/or morphine metabolites 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#

Type, Value, Unit table
TypeValueUnit
Length72Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)854-0530custserv@mpbio.com

Regulatory Flags#

DUNS number
008028248
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817830020166RAPID DIAGNOSTICS MARIJUANA (THC) TEST STRIP KIT (50)07RD800907RD80092016-10-20
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
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
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
00817830020258RAPID DIAGNOSTICS BUPRENORPHINE TEST STRIP KIT (50)07RD810507RD81052016-10-24

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