FDA.reportPublic FDA data

PRIME SCREEN®

Primary DI
00810174471137
Brand
PRIME SCREEN®
Company
WONDFO USA CO., LTD.
Model
DSODOA-166EUO
Device description
6-Panel T-Swab; AMP-COC- OPI;MET-THC-PCP
Published
2025-12-03
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUXTest, Amphetamine, Employment And Insurance Testing, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUXTest, Amphetamine, Employment And Insurance Testing, ExemptClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810174471144PrimaryGS10
00810174471137Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810174471144008101744711448101744711440810174471144
00810174471137008101744711378101744711370810174471137

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse 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 multiple drugs of abuse 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

Contacts#

Phone, Email table
PhoneEmail
630-468-2199wondfo@wondfousa.com

Regulatory Flags#

DUNS number
849098897
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
00816862027303WELLlife™WCOV-CON-52026-06-01
00816862028416WELLlife™WCOVID-POC-252026-06-01
00816862028294SAFElife™CDOA-L11135A32026-05-15
00816862028324WELLlife™ WFOB-OTC-2BX2026-05-15
00816862028348SAFElife™CDOA-6135F2026-05-15
00816862028362SAFElife™TDOA-6135F2026-05-15
00816862028393SAFElife™WEDDP-1142026-05-15
00816862028249SAFElife™CDOA-12135NT2026-01-15
00816862028270HORMONElife™H1-S-20BG2026-01-15
00816862027723HORMONElife™H1-S-E10-25BX-CLIA2026-01-15
00816862028164SAFElife™CDOA-12135NT2026-01-15
00816862028263HORMONElife™H1-S-20BG2026-01-15
00816862028027SAFElife™CDOA-L111452025-12-15
00816862028089SAFElife™CDOA-L11135A32025-12-15
00816862028102HORMONElife™H2-S-50BG2025-12-15
00816862028157HORMONElife™H1-C-25BX-CLIA2025-12-15
00816862028010SAFElife™CDOA-L111452025-12-15
00816862028072SAFElife™CDOA-L11135A32025-12-15
00816862028096HORMONElife™H2-S-50BG2025-12-15
00816862028119HORMONElife™H1-C-25BX-CLIA2025-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G474M310601EI0mLife ClassicMlife Diagnostics, LLCPUX2026-04-29
G474M321002EI0mLife VerifyMlife Diagnostics, LLCPUX2026-04-29
G474M310501EI0mLife ClassicMlife Diagnostics, LLCPUX2026-04-03
B29880913EI0DrugCheck Express Diagnostic Int'l, Inc.PUX2026-02-23
B29880502EI0DrugCheck Express Diagnostic Int'l, Inc.PUX2026-02-20
G474M321001EI0mLife VerifyMlife Diagnostics, LLCPUX2026-01-29
00810174470963PRIME SCREEN®WONDFO USA CO., LTD.PUX2025-12-05
00810174471007PRIME SCREEN®WONDFO USA CO., LTD.PUX2025-12-05
00810174471182SAFElife™WONDFO USA CO., LTD.PUX2025-12-05
00810174471212PRIME SCREEN®WONDFO USA CO., LTD.PUX2025-12-05
00810174470956PRIME SCREEN®WONDFO USA CO., LTD.PUX2025-12-05
00810174470994PRIME SCREEN®WONDFO USA CO., LTD.PUX2025-12-05
00810174471144PRIME SCREEN®WONDFO USA CO., LTD.PUX2025-12-03
00810174471168PRIME SCREEN®WONDFO USA CO., LTD.PUX2025-12-03
00810174471151PRIME SCREEN®WONDFO USA CO., LTD.PUX2025-12-03
G474M3209010VerifyMlife Diagnostics, LLCPUX2025-09-05
G474M3208010VerifyMlife Diagnostics, LLCPUX2025-07-21
00816862026634Prime ScreenWONDFO USA CO., LTD.PUX2025-07-03
10816862026631Prime ScreenWONDFO USA CO., LTD.PUX2025-07-03
G474M3106010ClassicMlife Diagnostics, LLCPUX2025-06-20
G474M3105010ClassicMlife Diagnostics, LLCPUX2025-06-19
00816862026337SAFElife™WONDFO USA CO., LTD.PUX2025-05-19
10816862026334SAFElife™WONDFO USA CO., LTD.PUX2025-05-19
G474MC002080001EI0ClassicMlife Diagnostics, LLCPUX2025-03-19
06977469280219S-Trust SE Oral Fluid Multi-Drug Test Cup(Colloidal Gold)Eterbio, Inc.PUX2024-12-18
G474MC001050002EI0ClassicMlife Diagnostics, LLCPUX2024-11-05
G474MV002110001EI0VerifyMlife Diagnostics, LLCPUX2024-10-08
00850054867704AmazewellGuangzhou Decheng Biotechnology Co., LTDPUX2024-09-30
00850054867711AmazewellGuangzhou Decheng Biotechnology Co., LTDPUX2024-09-30
00850054867728AmazewellGuangzhou Decheng Biotechnology Co., LTDPUX2024-09-30