FDA.reportPublic FDA data

NA

Primary DI
00841824102309
Brand
NA
Company
W.H.P.M. INC.
Model
WPC-25
Catalog number
WPC-25
Device description
DOA Single Test Dipcard, 25Pcs/Box Clia Waived PCP
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
LCMEnzyme Immunoassay, Phencyclidine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCMEnzyme Immunoassay, PhencyclidineUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841824102309PrimaryGS10
00841824100145Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841824102309008418241023098418241023090841824102309
00841824100145008418241001458418241001450841824100145

GMDN Terms#

Term, Definition table
TermDefinition
Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT)A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of phencyclidine (PCP) in a clinical specimen, using an immunochromatographic test (ICT) method.

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
Primary DIBrandCompanyProduct codePublished
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10810173655566HealgenHealgen Scientific Limited Liability CompanyLCM2026-02-04
00810173654920HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-31
00810173655071HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-31
10810173655085HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-31
10810173654774HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-08
10810173654798HealgenHealgen Scientific Limited Liability CompanyLCM2026-01-08
00812101031599ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
00812101031605ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
00812101031612ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
00812101031995ARK™ Ketamine II AssayARK DIAGNOSTICS INCLCM2025-12-27
10810173654538Healgen Healgen Scientific Limited Liability CompanyLCM2025-12-19
10810173654576HealgenHealgen Scientific Limited Liability CompanyLCM2025-12-19
10810173654637HealgenHealgen Scientific Limited Liability CompanyLCM2025-12-19
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00850013035878Identify® Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLCM2025-12-04
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10816862026358SAFElife™WONDFO USA CO., LTD.LCM2024-12-24
10815845023162SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.LCM2024-12-17
00817763022510First Sign®HEMOSURE INC.LCM2024-10-16
00812203030780DrugSmart CupCHEMTRON BIOTECH INCLCM2024-07-29
10810124273245SureStepTM Urine Test Drug Screen Strip, Phencyclidine (PCP 25)ALERE SAN DIEGO, INC.LCM2023-12-15
00858886006827Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCLCM2023-10-20
00817815021119CRL STAT CupCLINICAL REFERENCE LABORATORY, INC.LCM2023-08-23
10690286000763PROFILE®-V MEDTOXScan®MEDTOX DIAGNOSTICS, INC.LCM2023-08-01
30817405023821iScreen™Instant Technologies, Inc.LCM2023-05-01
30817405023883iScreen™Instant Technologies, Inc.LCM2023-05-01
30817405021711iScreen™Instant Technologies, Inc.LCM2023-02-07