FDA.reportPublic FDA data

First Sign®

Primary DI
00857338006330
Brand
First Sign®
Company
HEMOSURE INC.
Model
F2-CT25C
Catalog number
F2-CT25C
Device description
First Sign hCG Pregnancy Urine/Serum Test Cassette (4mm); 25Pcs/Box for Hemosure
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
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
00857338006330PrimaryGS10
00857338006231Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857338006330008573380063308573380063300857338006330
00857338006231008573380062318573380062310857338006231

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806777541
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
00817763022510First Sign®FSCCUP-13124 W/AD7FSCCUP-13124 W/AD72024-10-16
00817763022824First SignFSCCUP-21124FSCCUP-211242023-07-05
00817763022367First SignFSCDIP1464FSCDIP14642023-05-18
00817763022572FIRST SIGN®FSCDIP7364FSCDIP73642022-04-21
00817763022541First Sign®FSCDIP7164FSCDIP7164P2020-01-08
00817763022466First Sign®FSCCUP-13124 W/ADFSCCUP-13124 W/ADP2019-10-21
00817763022442FIRST SIGN®FSCDIP3384FSCDIP33842019-05-14
00817763022428FIRST SIGN®FSCCUP-3864FSCCUP-38642019-04-29
00817763020158FIRST SIGN®D0115TC-01D0115TC-012016-09-21
00817763020165FIRST SIGN®D0115TC-02D0115TC-022016-09-21
00857338006163HEMOSURE®T1-TC02T1-TC022016-08-24
00817763022244First Sign®FSCCUP-6664 W/AD72018-07-23
00817763022268First Sign®FSCCUP-20104 W/AD72018-07-23
00817763022220First Sign®FSCCUP-13124 W/AD82018-06-18
00817763022206First Sign®FSCDIP17242018-05-22
00817763022183First Sign®FSCDIP50542018-05-14
00817763022046First Sign®FSCDIPBA-252018-05-09
00817763022060First Sign®FSCDIPED-252018-05-09
00817763022084First Sign®FSCDIPMD-252018-05-09
00817763022107First Sign®FSCDIPMO-252018-05-09

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