FDA.reportPublic FDA data

Drugs of Abuse Five (5) Panel Test

Primary DI
00840239037732
Brand
Drugs of Abuse Five (5) Panel Test
Company
DRG International Inc
Model
RAP-3773
Catalog number
RAP-3773
Device description
The Drugs of Abuse (DOA-5) Panel Test is set up as a one step in-vitro test based on immunochromatography. It isdesigned for the qualitative determination of 5 drug substances, specifically Amphetamine, Benzodiazepine, Cocaine,Opiate, and Cannabinoid in human urine specimens.
Published
2019-06-10
Public version status
Update
Distribution status
Not 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
DKZEnzyme immunoassay, amphetamine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003809000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003809000RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELSRapid Diagnostics, Inc.2001-04-20DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239037732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239037732008402390377328402390377320840239037732

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, thin layer chromatographyA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen, using a thin layer chromatography method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(973)564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
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00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
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Primary DI, Brand, Company table
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