FDA.reportPublic FDA data

Prime Screen

Primary DI
00816862026191
Brand
Prime Screen
Company
WONDFO USA CO., LTD.
Model
DSODOA-116-COT-P
Device description
1-Panel T-Swab; COT 30ng/ml
Published
2024-12-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRSTest System, Nicotine, Cotinine, Metabolites

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRSTest System, Nicotine, Cotinine, MetabolitesClinical Toxicology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816862026198PackageGS198In Commercial Distribution
00816862026191PrimaryGS10
00816862026184Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081686202619810816862026198
00816862026191008168620261918168620261910816862026191
00816862026184008168620261848168620261840816862026184

GMDN Terms#

Term, Definition table
TermDefinition
Cotinine 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 cotinine (nicotine metabolite) 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 to aid in the differentiation of smokers and non-smokers, or in the investigation of the link between smoking and associated disorders (e.g., cancer, coronary heart disease, stroke). It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
849098897
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
06936983197090iScreenTM Oral Fluid Drug TestHangzhou AllTest Biotech Co., Ltd.MRS2025-09-26
06974246462349FIRSTVIEW COT Urine Dip Card TestSafecare Biotech (Hangzhou) Co., Ltd.MRS2025-07-07
06970429843417co-innovationCo-Innovation Biotech Co., LtdMRS2025-05-19
16970429843414co-innovationCo-Innovation Biotech Co., LtdMRS2025-05-19
06936983177252FirstCheck Cotinine Oral Fluid TestHangzhou AllTest Biotech Co., Ltd.MRS2025-02-14
10816862026198Prime ScreenWONDFO USA CO., LTD.MRS2024-12-24
06977469280097U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold)Eterbio, Inc.MRS2024-12-18
06977469280158U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold) Eterbio, Inc.MRS2024-12-18
00850065976280UScreen OralGuangzhou Decheng Biotechnology Co., LTDMRS2024-09-27
00850065976297UScreen OralGuangzhou Decheng Biotechnology Co., LTDMRS2024-09-27
00850065976303UScreen OralGuangzhou Decheng Biotechnology Co., LTDMRS2024-09-27
00850054867025AmazewellGuangzhou Decheng Biotechnology Co., LTDMRS2024-09-26
30850054867026AmazewellGuangzhou Decheng Biotechnology Co., LTDMRS2024-09-26
00810038636443Easy@Home Nicotine Urine Test (5 tests one kit)EASY HEALTHCARE CORPORATIONMRS2024-07-17
20810038636447Easy@Home Nicotine Urine Test (5 tests one kit)EASY HEALTHCARE CORPORATIONMRS2024-07-17
06974246461465T Testahead Cotinine(COT) Urine Test DipcardSafecare Biotech (Hangzhou) Co., Ltd.MRS2024-06-27
06974246461472T Testahead Cotinine(COT) Urine Test DipcardSafecare Biotech (Hangzhou) Co., Ltd.MRS2024-06-27
06974246461489T Testahead Cotinine(COT) Urine Test DipcardSafecare Biotech (Hangzhou) Co., Ltd.MRS2024-06-27
06974246460987EXPLORO Highly Sensitive NICOTINE URINE TESTSafecare Biotech (Hangzhou) Co., Ltd.MRS2023-12-01
06974246460994EXPLORO Highly Sensitive NICOTINE URINE TESTSafecare Biotech (Hangzhou) Co., Ltd.MRS2023-12-01
06974246461007EXPLORO Highly Sensitive NICOTINE URINE TESTSafecare Biotech (Hangzhou) Co., Ltd.MRS2023-12-01
06974246461014EXPLORO Highly Sensitive NICOTINE URINE TESTSafecare Biotech (Hangzhou) Co., Ltd.MRS2023-12-01
06974246460840FIRSTVIEW COT Urine Dip card TestSafecare Biotech (Hangzhou) Co., Ltd.MRS2023-09-05
04048474059175Cotinine ELISADRG Instruments Gesellschaft mit beschränkter HaftungMRS2023-09-01
00810038634654Areta Cotinine Test Strip -COT(10 tests one kit)EASY HEALTHCARE CORPORATIONMRS2023-07-19
00810038634661Areta Cotinine Test Strip(25tests one kit)EASY HEALTHCARE CORPORATIONMRS2023-07-19
30810038634655Areta Cotinine Test Strip -COT(10 tests one kit)EASY HEALTHCARE CORPORATIONMRS2023-07-19
30810038634662Areta Cotinine Test Strip(25tests one kit)EASY HEALTHCARE CORPORATIONMRS2023-07-19
06972428162186U-CatchShenzhen Bioeasy Biotechnology Co., LtdMRS2023-03-09
06974246460727Highly Sensitive Nicotine Urine TestSafecare Biotech (Hangzhou) Co., Ltd.MRS2023-02-16