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Address: 12076 Santa Fe Drive, P.O. Box 14428, Lenexa, Kansas 66215, USA
www.remelinc.com |
Send Inquiry |
Phone: +1-(913)-888-0939
FDA Registration: 1031428 Year Established: 1973
Employee Count: ~20
Products: Pregnancy Kits, Cotton Swabs, Home pregnancy test kits, Hcg, Early Pregnancy Testing Kit, Sensitive Pregnancy Tests, Diagnostic Test Kits For Pregnancy, ...
Remel offers a wide range of microbiology products that are used in the clinical, industrial, research and academic laboratories. Our products help diagnose infection quickly and accurately, providing
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Address: 1055 East State St., Suite 100, Athens, Ohio 45701, USA
www.dhiusa.com |
Send Inquiry |
Phone: +1-(740)-589-3300, 800-344-5847
FDA Registration: 1528450 Year Established: 1983
Quality: ISO 13485 Certified
Products: Swabs, Endocrine/Thyroid Testing, Influenza A, B Test Kits, Diagnostic Kits, Influenza A&B Kit, Flocked Swabs, ...
Diagnostic Hybrids innovates, develops, manufactures and markets cellular & molecular diagnostic kits for various applications in detecting a wide range of respiratory diseases, herpes infections, thy
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Address: Tullagreen, Carrigtwohill, Ireland
www.millipore.com/offices/cp3/ie |
Phone: +353-(21)-488 36 66
FDA Registration: 8020892
Products: Reverse Osmosis Water Purifier Purification, Medical Ultraviolet Water Purifiers (FDA Code:
KMG), Water Purifier (FDA Code:
JRS), Anesthetic Conduction Filter (FDA Code:
BSN), Membrane Filter Unit (FDA Code:
JRL), Infusion Line Filter (FDA Code:
FPB), ...
Millipore Ireland B.V. provides technologies, tools and services for bioscience research & biopharmaceutical manufacturing. We offer products and services in life sciences, drug discovery & developmen
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FDA Code / Regulation: GOE / 866.3405 Poliovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to poliovirus in serum. Additionally, some of these reagents consist of poliovirus antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify polioviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of poliomyelitis (polio) and provides epidemiological information on this disease. Poliomyelitis is an acute infectious disease which in its serious form affects the central nervous system resulting in atrophy (wasting away) of groups of muscles, ending in contraction and permanent deformity.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 866.9.