Home GUDID 00810174470505 HORMONElife™
Primary DI 00810174470505
Brand HORMONElife™
Company WONDFO USA CO., LTD.
Model DW199-S-12BX-H
Device description HORMONELife PDG test, 12T/Box
Published 2025-07-04
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Single use true Product Codes# Code, Name table Code Name QKE Immunoassay, Pregnanediol Glucuronide, Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QKE Immunoassay, Pregnanediol Glucuronide, Over The Counter Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10810174470502 Package GS1 180 In Commercial Distribution 00810174470505 Primary GS1 0 00810174470604 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10810174470502 10810174470502 00810174470505 00810174470505 810174470505 0810174470505 00810174470604 00810174470604 810174470604 0810174470604
GMDN Terms# Term, Definition table Term Definition Multiple female fertility marker IVD, kit, rapid ICT, clinical A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of a combination of different types of female fertility markers [e.g., estrone-3-glucuronide (E1-3G), pregnanediol-3-glucuronide (PdG), luteinizing hormone (LH) and follicle stimulating hormone (FSH)] in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 4 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 849098897 Device count 12 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06974464591272 One Step® Progesterone (PdG) Urine Test Strip Guangzhou Decheng Biotechnology Co., LTD QKE 2026-03-31 00850035206393 Proov Mfb Fertility, Inc. QKE 2025-08-15 00810038637150 easy@Home PdG Urine Test Strip EASY HEALTHCARE CORPORATION QKE 2025-07-24 00810038638041 easy@Home PdG Urine Test Strip EASY HEALTHCARE CORPORATION QKE 2025-07-24 10810038637157 easy@Home PdG Urine Test Strip EASY HEALTHCARE CORPORATION QKE 2025-07-24 10810038638048 easy@Home PdG Urine Test Strip EASY HEALTHCARE CORPORATION QKE 2025-07-24 00816862027266 HORMONElife™ WONDFO USA CO., LTD. QKE 2025-07-03 10816862027263 HORMONElife™ WONDFO USA CO., LTD. QKE 2025-07-03 00990312537984 Eli Progesterone Hormometer™ Eli Science Inc QKE 2025-05-05 00810143620207 GenaCheck®PdG At-Home Ovulation Confirmation Test Genabio Diagnostics Inc. QKE 2025-01-13 00816862024081 Wondfo WONDFO USA CO., LTD. QKE 2024-12-31 10816862024088 Wondfo WONDFO USA CO., LTD. QKE 2024-12-31 00816862026436 Wondfo WONDFO USA CO., LTD. QKE 2024-12-24 10816862026433 Wondfo WONDFO USA CO., LTD. QKE 2024-12-24 00850054867469 Amazewell Guangzhou Decheng Biotechnology Co., LTD QKE 2024-09-30 00850054867544 Amazewell Guangzhou Decheng Biotechnology Co., LTD QKE 2024-09-30 30850054867460 Amazewell Guangzhou Decheng Biotechnology Co., LTD QKE 2024-09-30 30850054867545 Amazewell Guangzhou Decheng Biotechnology Co., LTD QKE 2024-09-30 00850035206157 Proov Mfb Fertility, Inc. QKE 2023-05-17 00850035206164 Proov Mfb Fertility, Inc. QKE 2023-05-17 00850035206065 Proov Mfb Fertility, Inc. QKE 2023-04-20 00850035206126 Proov Mfb Fertility, Inc. QKE 2023-03-28 00860002790817 Proov Mfb Fertility, Inc. QKE 2023-03-24
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