FDA.report

NA

Primary DI
00841824102767
Brand
NA
Company
W.H.P.M. INC.
Model
W1564
Catalog number
W1564
Device description
DOA 6 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/THC
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites

Product Code Classifications

CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841824102767PrimaryGS10
00841824100565Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841824102767008418241027678418241027670841824102767
00841824100565008418241005658418241005650841824100565

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
602085672
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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

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