FDA.reportPublic FDA data

Amazewell

Primary DI
30850054867545
Brand
Amazewell
Company
Guangzhou Decheng Biotechnology Co., LTD
Model
APDG-10E
Device description
Amazewell PdG Urine Test Strip, 10T/Bag
Published
2024-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
QKEImmunoassay, Pregnanediol Glucuronide, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKEImmunoassay, Pregnanediol Glucuronide, Over The CounterClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850054867544PrimaryGS10
30850054867545Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054867544008500548675448500548675440850054867544
3085005486754530850054867545

GMDN Terms#

Term, Definition table
TermDefinition
Multiple female fertility marker IVD, kit, rapid ICT, clinicalA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554534314
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
06974464591272One Step® Progesterone (PdG) Urine Test Strip6T2026-03-31
06974464591296One Step® LH Ovulation Rapid Test Dipstick (Urine)20T2026-03-31
06974464591302One Step® LH Ovulation Rapid Test Dipstick (Urine)30T2026-03-31
06974464591319One Step® LH Ovulation Rapid Test Dipstick (Urine)60T2026-03-31
06974464591333One Step® HCG Early Rapid Pregnancy Midstream Test5T2026-03-31
06974464591340One Step® HCG Early Rapid Pregnancy Strips15T2026-03-31
06974464591357One Step® 7-PANEL MULTI DRUG URINE TEST5T2026-03-31
00075450847635Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestIT415-3/V4072026-02-20
00075450847666Hy-Vee® Analog Pregnancy Rapid TestIT000416-2/V4072026-02-20
00075450847673Hy-Vee® Digital Pregnancy Rapid TestIT000417-2/V4072026-02-20
00075450847680Hy-Vee® Ovulation KitIT000418-11/V4072026-02-20
30075450847636Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestIT415-3/V4072026-02-20
00075450847642Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestIT415-2/V4072026-02-20
00075450847659Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestIT415-1/V4072026-02-20
30075450847667Hy-Vee® Analog Pregnancy Rapid TestIT000416-2/V4072026-02-20
30075450847674Hy-Vee® Digital Pregnancy Rapid TestIT000417-2/V4072026-02-20
30075450847681Hy-Vee® Ovulation KitIT000418-11/V4072026-02-20
00045611010000SURESIGN™ Pregnancy Rapid Test01000-02026-01-28
00045611010017SURESIGN™ Early Detection Pregnancy Test01001-72026-01-28
00045611010024SURESIGN™ Digital Pregnancy Rapid Test01002-42026-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974464591272One Step® Progesterone (PdG) Urine Test StripGuangzhou Decheng Biotechnology Co., LTDQKE2026-03-31
00850035206393ProovMfb Fertility, Inc.QKE2025-08-15
00810038637150easy@Home PdG Urine Test StripEASY HEALTHCARE CORPORATIONQKE2025-07-24
00810038638041easy@Home PdG Urine Test StripEASY HEALTHCARE CORPORATIONQKE2025-07-24
10810038637157easy@Home PdG Urine Test StripEASY HEALTHCARE CORPORATIONQKE2025-07-24
10810038638048easy@Home PdG Urine Test StripEASY HEALTHCARE CORPORATIONQKE2025-07-24
00810174470505HORMONElife™WONDFO USA CO., LTD.QKE2025-07-04
00816862027266HORMONElife™WONDFO USA CO., LTD.QKE2025-07-03
10816862027263HORMONElife™WONDFO USA CO., LTD.QKE2025-07-03
00990312537984 Eli Progesterone Hormometer™Eli Science IncQKE2025-05-05
00810143620207GenaCheck®PdG At-Home Ovulation Confirmation TestGenabio Diagnostics Inc.QKE2025-01-13
00816862024081WondfoWONDFO USA CO., LTD.QKE2024-12-31
10816862024088WondfoWONDFO USA CO., LTD.QKE2024-12-31
00816862026436WondfoWONDFO USA CO., LTD.QKE2024-12-24
10816862026433WondfoWONDFO USA CO., LTD.QKE2024-12-24
00850054867469AmazewellGuangzhou Decheng Biotechnology Co., LTDQKE2024-09-30
00850054867544AmazewellGuangzhou Decheng Biotechnology Co., LTDQKE2024-09-30
30850054867460AmazewellGuangzhou Decheng Biotechnology Co., LTDQKE2024-09-30
00850035206157ProovMfb Fertility, Inc.QKE2023-05-17
00850035206164ProovMfb Fertility, Inc.QKE2023-05-17
00850035206065ProovMfb Fertility, Inc.QKE2023-04-20
00850035206126ProovMfb Fertility, Inc.QKE2023-03-28
00860002790817ProovMfb Fertility, Inc.QKE2023-03-24