FDA.reportPublic FDA data

Amazewell

Primary DI
30850054867118
Brand
Amazewell
Company
Guangzhou Decheng Biotechnology Co., LTD
Model
DPO-744EUO
Device description
Amazewell™ D-Pen™ Oral Fluid Drug Test, 4-Panel , 25T/Box
Published
2024-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
PUYTest, Barbiturate, Employment And Insurance Testing, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUYTest, Barbiturate, Employment And Insurance Testing, ExemptClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850054867117PrimaryGS10
30850054867118Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054867117008500548671178500548671170850054867117
3085005486711830850054867118

GMDN Terms#

Term, Definition table
TermDefinition
Amphetamine-specific 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 specific amphetamine 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
25
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
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
06974464591654One Step® LH Ovulation Rapid Test Dipstick (Urine)45T2026-07-15
06974464591678One Step® LH Ovulation Rapid Test Dipstick (Urine)40T2026-07-22
06974464591685One Step® LH Ovulation Rapid Test Dipstick (Urine)50T2026-07-22
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
00850081966005Pregmate50T2026-07-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B29881100AEI0DrugCheckExpress Diagnostic Int'l, Inc.PUY2026-08-25
B29880913EI0DrugCheck Express Diagnostic Int'l, Inc.PUY2026-02-23
00810174471182SAFElife™WONDFO USA CO., LTD.PUY2025-12-05
00810174471168PRIME SCREEN®WONDFO USA CO., LTD.PUY2025-12-03
G474M3209010VerifyMlife Diagnostics, LLCPUY2025-09-05
G474M3208010VerifyMlife Diagnostics, LLCPUY2025-07-21
G474MV002110001EI0VerifyMlife Diagnostics, LLCPUY2024-10-08
00850054867704AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-30
00850054867711AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-30
00850054867728AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-30
00850054867735AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-30
00850054867896AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-29
00850054867964AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-29
00850054867773AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-29
00850054867797AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-29
00850054867803AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-29
30850054867965AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-29
00850054867100AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-27
00850054867117AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-27
00850054867131AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-27
00850065976280UScreen OralGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-27
00850065976297UScreen OralGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-27
00383173000221MGC HEALTHGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-27
00850065976303UScreen OralGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-27
00850054867049AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-26
00850054867056AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-26
00850054867070AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-26
00850054867087AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-26
00850054867094AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-26
00850054867148AmazewellGuangzhou Decheng Biotechnology Co., LTDPUY2024-09-26