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AT First Diagnostics uses a FDA registered medical device & drug facility. Our quality systems are certified to ISO 13485:2003 standards. We are compliant with QSR (cGMP). Manufacturing and in-line packaging are performed in our Class 10,000 cleanroom (Class 7 per ISO 14644-1) to meet or exceed the rigorous regulatory demands of today's global marketplace. The research team is located in Princeton, New Jersey and follows a methodology that matches the FDA 21 CFR 820 elements. The product development team transfers the design from prototype phase to volume manufacturing.
 Manufacturing services are established at our facility in Princeton, New Jersey and extra international capacity in China. The Princeton team handles the full manufacturing spectrum, from vendor selection, reliability testing, system documentation, production planning, returns failure analysis and CAPA activities. AT First International (China) is ISO 9001:2000 certified.
AT First Diagnostics directs all operations at our selected China Contract Manufacturing site. The Contract Manufacture is ISO 13485 certified, cGMP compliant and ROHS compliant. The manufacturing operation is designed to be scalable from low volume prototyping to high volume production.
AT First Diagnostic Rapid Field Tests are used in over 40 countries including; Africa, Malaysia, Canada, United States, Germany, Belgium, Spain, Turkey, Australia, Hong Kong, Korea, Africa, Mexico, Middle East...
ATF-B102 Pregnancy (hCG) Rapid Strips(Urine)
ATF-B103 Ovulation (LH) Rapid Strips (Urine)
ATF-B104 FSH Menopausal Test Strips (Urine)
ATF-B105 HBsAb One Step Hepatitis B Surface Antibody Strips (Serum/Plasma)
ATF-B106 HBsAb Rapid Hepatitis B Surface Antibody Strips (Whole Blood/Serum/Plasma)
ATF-B107 HBsAg One Step Hepatitis B Surface Antigen Strips (Serum/Plasma)
ATF-B108 HBsAg Rapid Hepatitis B Surface Antigen Strips (Whole Blood/Serum/Plasma)
ATF-B109 HBeAb One Step Heptitis B Envelope Antibody Strips (Serum/Plasma)
ATF-B110 HBeAg One Step Heptitis B Envelope Antigen Strips (Serum/Plasma)
ATF-B112 HCV Rapid Hepatitis C Virus Strips (Serum/Plasma)
ATF-B113 HCV Rapid Hepatitis C Virus Strips (Whole Blood/Serum/Plasma)
ATF-B114 HIV Rapid Strips (Serum/Plasma)
ATF-B115 HIV Rapid Strips (Whole Blood/Serum/Plasma)
ATF-B116 HIV 1/2/O Tri-line Rapid Strips (Whole Blood/Serum/Plasma)
ATF-B117 H. pylori Rapid Strips (Whole Blood/Serum/Plasma)
ATF-B118 Malaria P.f. Rapid Strips (Whole Blood)
ATF-B119 MONO Mononucleosis Rapid Strips (Whole Blood/Serum/Plasma)
ATF-B120 Strep A Rapid Strips (Throat Swab)
ATF-B121 Syphilis One Step Strips (Serum/Plasma)
ATF-B122 Rubella Rapid Antibody (IgG/IgM) Strips (Whole Blood/Serum/Plasma)
ATF-B123 Lyme Rapid Antibody (IgG) Strips (Whole Blood/Serum/Plasma)
ATF-B124 Dengue virus IgG and IgM Strips (Whole Blood/Serum/Plasma)
ATF-B125 Salmonella typhi IgG/IgM Strips (Whole Blood/Serum/Plasma)
ATF-B126 TB Tuberculosis Test (Whole Blood/Serum/Plasma)
 Strip Format: (Bulk) is the Preferred method for in field testing centers. The Strip format is a One-Step dipstick test designed for clinical and professional use in the field. To use the strip, simply immerse one end of the test strip into the specimen, leave the strip in the specimen for 3 seconds, and lay the strip flat on a clean, dry, non-absorbent surface. Results appear within minutes as either single or double bands. The Strip format is a fast, accurate, very cost-effective and easy-to-use.
Bulk Strips Packaging: 24” x 18” x 18” carton contains:
10,000 pcs - strips (bulk)
2,000 pcs – 2,5000pcs cassettes (retail)
1,600 pcs - midstream wands (bulk)
Container Loads:
Bulk, 20 ft, 240 cartons, est. 400,000 – 550,000 units
Bulk, 40 ft, 500 cartons, est. 800,000 - 1.1 million units
Clinic, 20 ft, 1,150 cartons, est. 30,000 units
Clinic, 40 ft, 2,600 cartons, est. 65,000 units
Retail, 20 ft, 575 cartons, est. 23,000
Retail, 40 ft, 1,300 cartons, est. 52,000
For information on how to get products in your country please contact our marketing office at sales@atfirstdiagnostic.com
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