FDA.reportPublic FDA data

NA

Primary DI
00841824102248
Brand
NA
Company
W.H.P.M. INC.
Model
F2-CK04
Catalog number
F2-CK04
Device description
hCG Pregnancy Urine/Serum Test Cassette (4mm), 25/plain white box
Published
2016-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JHIVisual, Pregnancy Hcg, Prescription Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHIVisual, Pregnancy Hcg, Prescription UseClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841824102248PrimaryGS10
00841824102378Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841824102248008418241022488418241022480841824102248
00841824102378008418241023788418241023780841824102378

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin (HCG) 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 total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, 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
50
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
80810164510101Atida hCG Pregnancy Rapid Combo TestACESO LABORATORIES INC.JHI2026-03-23
00816862027723HORMONElife™WONDFO USA CO., LTD.JHI2026-01-15
00850082766000QMedix™Diagnostic Automation, Inc.JHI2025-12-24
00816862028119HORMONElife™WONDFO USA CO., LTD.JHI2025-12-15
10612479280134McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-12-10
10612479280158McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-12-10
10612479279855MckessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-08-14
10612479279862McKessonMCKESSON MEDICAL-SURGICAL INC.JHI2025-08-14
56952062778160HCG Home Use Pregnancy Test Midstream (Colloidal Gold)ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTDJHI2025-02-12
10673486002454Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestTECO DIAGNOSTICSJHI2024-12-19
00850054026651QMedix™Diagnostic Automation, Inc.JHI2024-06-25
10197344024995MedlineMEDLINE INDUSTRIES, INC.JHI2024-03-11
10673486002409Teco Diagnostics One-Step Urine/Serum Combo Pregnancy Card TestTECO DIAGNOSTICSJHI2024-01-16
10673486002379TECO DIAGNOSTICS ONE-STEP PREGNANCY DIPSTICK TESTTECO DIAGNOSTICSJHI2023-10-26
10816862023784PreviewWONDFO USA CO., LTD.JHI2023-08-03
10816862023807WondfoWONDFO USA CO., LTD.JHI2023-08-03
00850051158096PrabadinPrabadin CorpJHI2023-06-08
00850035206164ProovMfb Fertility, Inc.JHI2023-05-17
00850035206126ProovMfb Fertility, Inc.JHI2023-03-28
00850035206003ProovMfb Fertility, Inc.JHI2023-03-24
15099590776886ICON 25 hCGBeckman Coulter, Inc.JHI2022-10-21
10888277703575MedlineMEDLINE INDUSTRIES, INC.JHI2022-06-08
10885380181153CARDINAL HEALTHCardinal Health 200, LLCJHI2022-02-22
10885380181191CARDINAL HEALTHCardinal Health 200, LLCJHI2022-02-22
10885380181177CARDINAL HEALTHCardinal Health 200, LLCJHI2022-01-11
10885380181184CARDINAL HEALTHCardinal Health 200, LLCJHI2022-01-11
10894175000081OneStepDiagnostic Automation, Inc.JHI2021-08-11
00817415020987DealmedDEALMED MEDICAL SUPPLIES LLCJHI2021-06-11
00083059104851EZ-hCG Urine Pregnancy TestBIOMERICA, INC.JHI2020-07-01
00630414294254Atellica IM ThCGSiemens Healthcare Diagnostics Inc.JHI2020-05-31