FDA.reportPublic FDA data

MP Saliva Alcohol Test Strip

Primary DI
00817830022825
Brand
MP Saliva Alcohol Test Strip
Company
RAPID DIAGNOSTICS INC
Model
07RD-7124
Catalog number
07RD-7124
Device description
Immunoassay: Semi-quantitative alcohol saliva test
Published
2017-08-03
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
DICALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme MethodClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817830022825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817830022825008178300228258178300228250817830022825

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length75Millimeter

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)854-0550custserv@mpbio.com

Regulatory Flags#

DUNS number
008028248
Device count
1
Premarket exempt
true
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654089Atellica CH Ethanol (EtohC)Siemens Healthcare Diagnostics Inc.DIC2025-10-15
00816862024531WondfoWONDFO USA CO., LTD.DIC2024-05-23
10816862024538WondfoWONDFO USA CO., LTD.DIC2024-05-23
10673486000993TECO DIAGNOSTICSTECO DIAGNOSTICSDIC2022-09-07
06970429841444co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841536co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841628co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841703co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841802co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
06970429841901co-innovationCo-Innovation Biotech Co., LtdDIC2022-01-15
00816862022995WondfoWONDFO USA CO., LTD.DIC2021-08-20
00816862023015WondfoWONDFO USA CO., LTD.DIC2021-08-20
10816862022992WondfoWONDFO USA CO., LTD.DIC2021-08-20
10816862023012WondfoWONDFO USA CO., LTD.DIC2021-08-20
06970429841611co-innovationCo-Innovation Biotech Co., LtdDIC2021-03-29
00811727017390Pointe Ethyl Alcohol Reagent SetHORIBA INSTRUMENTS INCORPORATEDDIC2020-09-25
00811727017406Pointe Ethyl Alcohol Reagent SetHORIBA INSTRUMENTS INCORPORATEDDIC2020-09-25
07613336121221Ethanol Gen.2Roche Diagnostics GmbHDIC2020-03-05
07613336157817Ethanol Gen.2Roche Diagnostics GmbHDIC2020-03-05
00816862022339WondfoWONDFO USA CO., LTD.DIC2020-02-20
10816862022336WondfoWONDFO USA CO., LTD.DIC2020-02-20
B2984090010AlcoCheckExpress Diagnostic Int'l, Inc.DIC2019-05-02
06970429841284co-innovationCo-Innovation Biotech Co., LtdDIC2019-03-22
26970429841288co-innovationCo-Innovation Biotech Co., LtdDIC2019-03-22
00628063401086Ethanol AssaySEKISUI DIAGNOSTICS, LLCDIC2018-11-28
00840937110355ImmunalysisIMMUNALYSIS CORPDIC2017-09-07
00840937110362ImmunalysisIMMUNALYSIS CORPDIC2017-09-07
00840937110379ImmunalysisIMMUNALYSIS CORPDIC2017-09-07
00840937110386ImmunalysisIMMUNALYSIS CORPDIC2017-09-07
B298409000AlcoCheckEXPRESS DIAGNOSTICS INT'L, INC.DIC2017-02-20