4 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci
FDA Enforcement
Class II
·Terminated·Remel Inc·December 25, 2013
Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci. Reagents are provided for groups A, B, C, D, F and G covering the majority of clinical isolates, group E streptococci are rarely isolated.
FDA Enforcement
Class II
·Terminated·Remel Inc·December 25, 2013
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
FDA Enforcement
Class II
·Ongoing·Remel Europe Ltd.·April 29, 2026
Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product Number: R30165501, UDI-DI: 05056080501826 - Product Usage: Bordetella antisera are suitable for use in slide agglutination tests to serologically identify Bordetella pertussis and Bordetella parapertussis for epidemiological and diagnostic purposes.
FDA Enforcement
Class II
·Terminated·Remel Europe Ltd.·September 9, 2020