FDA.reportPublic FDA data

NA

Primary DI
00841824102705
Brand
NA
Company
W.H.P.M. INC.
Model
W4464
Catalog number
W4464
Device description
DOA 6 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BZO/COC/MOR/MTD/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

Product Codes#

Code, Name table
CodeName
DJREnzyme Immunoassay, Methadone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJREnzyme Immunoassay, MethadoneClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841824102705PrimaryGS10
00841824100510Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841824102705008418241027058418241027050841824102705
00841824100510008418241005108418241005100841824100510

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.

Sterilization Methods#

Method table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841824101845ECOIIECOII-6664ECOII-66642026-03-19
00841824105706N/AW944W9442025-12-04
00841824105683EZ CLICKEZ-77104 W/ADEZ-77104 W/AD2025-11-20
00841824105645N/AWMA500-25WMA500-252025-06-13
00841824105553ECOIIECOII-07144ECOII-071442024-08-22
00841824104730EZ CLICKEZ-13124 W/ADEZ-13124 W/AD2024-07-25
00841824105409N/AW4374W43742024-06-14
00841824105492ECOIIECOII-4104 W/AD2ECOII-4104 W/AD22024-04-26
00841824105454N/AW4494W44942024-04-08
00841824105348ECOIIECOII-83104ECOII-831042023-06-15
00841824105249ECOIIECOII-87114ECOII-871142023-05-18
00841824105300ECOIIECOII-2744 W/AD9ECOII-2744 W/AD92023-05-18
00817763022770Hemosure® Accu-Reader® A1002023-05-10
00841824101708ECO II CupECOII-73124 W/AD4ECOII-73124 W/AD42022-11-01
00817763022787First Sign®FSCCUP-3994FSCCUP-39942023-02-14
00841824105034N/AW15134W151342023-02-14
00841824105188ECO II CupECOII-22114ECOII-221142022-12-01
00817815020730CRL STATKCUR920127KCUR9201272022-11-22
00817763022602First SignFSCDIP18114FSCDIP181142022-11-17
00841824105164n/aW6074 W/AD6W6074 W/AD62022-11-16

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Primary DI, Brand, Company table
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00810173655507Healgen Healgen Scientific Limited Liability CompanyDJR2026-02-04
10810173655580HealgenHealgen Scientific Limited Liability CompanyDJR2026-02-04
00810173654944HealgenHealgen Scientific Limited Liability CompanyDJR2026-01-31
00810173654951HealgenHealgen Scientific Limited Liability CompanyDJR2026-01-31
00810173655033HealgenHealgen Scientific Limited Liability CompanyDJR2026-01-31
10810173655634HealgenHealgen Scientific Limited Liability CompanyDJR2026-01-30
10810173654750Healgen Healgen Scientific Limited Liability CompanyDJR2026-01-08
10810173653999HealgenHealgen Scientific Limited Liability CompanyDJR2025-12-19
10810173654569HealgenHealgen Scientific Limited Liability CompanyDJR2025-12-19
10810173654613HealgenHealgen Scientific Limited Liability CompanyDJR2025-12-19
10810173654668HealgenHealgen Scientific Limited Liability CompanyDJR2025-12-19
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