D-81649002RNG01LEKY B-81649002RNG01LEKY D-81649002RNG01LEKY Rapid Varicella-Zoster Virus DNA Test Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105010203 GONOCOCCAL DETECTION BY NA REAGENTS Piyasada RNG01-AHG5E/ RNG01-AHG25E Germany 2026-07-12T07:05:28.935Z D-81649002RMTB01N5WX B-81649002RMTB01N5WX D-81649002RMTB01N5WX Rapid MTBC DNA Test Healgen Life Science LLC US-MF-000043017 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105010703 MYCOBACTERIAL DETECTION BY NA REAGENTS Piyasada RMTB01-AHG5E, RMTB01-AHG25E Germany 2026-07-12T07:05:27.330Z D-81649002RGAS01JKST B-81649002RGAS01JKST D-81649002RGAS01JKST Rapid Group A Streptococcus DNA Test Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105011103 STREP. A DETECTION BY NA REAGENTS Piyasada RGAS01-AHG5E/ RGAS01-AHG25E Germany 2026-07-12T07:05:21.747Z D-81649002CGBS01AC2NU B-81649002CGBS01AC2NU D-81649002CGBS01AC2NU GeneStream GBS Assay Healgen Life Science LLC US-MF-000043017 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105011102 STREPTOCOCCAL DETECTION BY NA REAGENTS Piyasada CGBS01A-AHG4E Germany 2026-07-12T07:04:56.054Z D-81649002CGBSZK01A7A8A B-81649002CGBSZK01A7A8A D-81649002CGBSZK01A7A8A GeneStream GBS Controls Healgen Life Science LLC US-MF-000043017 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105011102 STREPTOCOCCAL DETECTION BY NA REAGENTS Piyasada CGBSZK01A-AHG4E Germany 2026-07-12T07:04:53.654Z D-81649002ATP01HAFU B-81649002ATP01HAFU D-81649002ATP01HAFU Treponema Pallidum Detection Kit (Fluorescence PCR) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105010305 SYPHILIS DETECTION BY NA REAGENTS Piyasada ATP01-AHG48E/ATP01-AHG96E/ATP01D-AHG48E/ATP01D-AHG96E Germany 2026-07-12T07:04:35.200Z D-81649002ATP01DFBL5 B-81649002ATP01DFBL5 D-81649002ATP01DFBL5 Treponema Pallidum Fluorescence PCR Kit (Lyophilized) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105010305 SYPHILIS DETECTION BY NA REAGENTS Piyasada ATP01D-AHG48E/ATP01D-AHG96E Germany 2026-07-12T07:04:33.613Z D-81649002ANG01EKAN B-81649002ANG01EKAN D-81649002ANG01EKAN Neisseria Gonorrhoeae Detection Kit (Fluorescence PCR) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105010203 GONOCOCCAL DETECTION BY NA REAGENTS Piyasada ANG01-AHG48E; ANG01-AHG96E; ANG01D-AHG48E; ANG01D-AHG96E Germany 2026-07-12T07:04:29.595Z D-81649002ANG01DBACU B-81649002ANG01DBACU D-81649002ANG01DBACU Neisseria Gonorrhoeae Fluorescence PCR Kit (Lyophilized) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105010203 GONOCOCCAL DETECTION BY NA REAGENTS Piyasada ANG01D-AHG48E; ANG01D-AHG96E Germany 2026-07-12T07:04:28.797Z D-81649002AMTBC01HNZE B-81649002AMTBC01HNZE D-81649002AMTBC01HNZE Mycobacterium Tuberculosis Complex Detection Kit (Fluorescence PCR) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105010703 MYCOBACTERIAL DETECTION BY NA REAGENTS Piyasada AMTBC01-AHG48E; AMTBC01-AHG96E; AMTBC01D-AHG48E; AMTBC01D-AHG96E Germany 2026-07-12T07:04:24.789Z D-81649002AMTBC01DNVDE B-81649002AMTBC01DNVDE D-81649002AMTBC01DNVDE Mycobacterium Tuberculosis Complex Fluorescence PCR Kit (Lyophilized) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105010703 MYCOBACTERIAL DETECTION BY NA REAGENTS Piyasada AMTBC01D-AHG48E, AMTBC01D-AHG96E Germany 2026-07-12T07:04:23.198Z D-81649002AMP01FRDV B-81649002AMP01FRDV D-81649002AMP01FRDV Mycoplasma Pneumoniae Detection Kit (Fluorescence PCR) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W010501080303 UREAPLASMA DETECTION BY NA REAGENTS Piyasada AMP01-AHG48E; AMP01-AHG96E; AMP01D-AHG48E; AMP01D-AHG96E Germany 2026-07-12T07:04:18.388Z D-81649002AMP01DCWHF B-81649002AMP01DCWHF D-81649002AMP01DCWHF Mycoplasma Pneumoniae Fluorescence PCR Kit (Lyophilized) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W010501080303 UREAPLASMA DETECTION BY NA REAGENTS Piyasada AMP01D-AHG48E; AMP01D-AHG96E Germany 2026-07-12T07:04:16.791Z D-81649002AGAS01BNG6 B-81649002AGAS01BNG6 D-81649002AGAS01BNG6 Group A Streptococcus Detection Kit (Fluorescence PCR) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105011103 STREP. A DETECTION BY NA REAGENTS Piyasada AGAS01-AHG48E; AGAS01D-AHG48E Germany 2026-07-12T07:00:02.354Z D-81649002AGAS01DATP8 B-81649002AGAS01DATP8 D-81649002AGAS01DATP8 Group A Streptococcus Fluorescence PCR Kit (Lyophilized) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105011103 STREP. A DETECTION BY NA REAGENTS Piyasada AGAS01-AHG48E; AGAS01D-AHG48E Germany 2026-07-12T06:59:59.929Z D-81649002ABPTS02JB59 B-81649002ABPTS02JB59 D-81649002ABPTS02JB59 Bordetella Pertussis Detection Kit (Fluorescence PCR) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105011607 BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS Piyasada ABPTS02-AHG48E/ ABPTS02-AHG96E Germany 2026-07-12T06:59:22.276Z D-7O02FA B-7O02FA Helicobacter Pylori IgG assay (CLIA) Helicobacter Pylori IgG assay (CLIA) Xiamen Boson Biotech Co., Ltd. CN-MF-000001096 MedPath GmbH DE-AR-000000087 IVD Genel IVDD W0105010402 H. PYLORI ANTIBODY ASSAYS Piyasada 7O02V1-B-EU, 7O02U1-B-EU, 7O02P1-B-EU Germany 2026-07-12T06:29:11.917Z D-7N02F5 B-7N02F5 Treponema Pallidum Antibody assay (CLIA) Treponema Pallidum Antibody assay (CLIA) Xiamen Boson Biotech Co., Ltd. CN-MF-000001096 MedPath GmbH DE-AR-000000087 IVD Genel IVDD W0105010302 SYPHILIS ANTIBODY ASSAYS TOTAL Piyasada 7N02V1-B-EU, 7N02U1-B-EU, 7N02P1-B-EU Germany 2026-07-12T06:29:11.116Z 48594036043990 B-48594036043990 ELISA-VIDITEST anti-Borelia recombinant IgM (CSF) VIDIA spol. s r.o. CZ-MF-000036964 IVD Genel IVDD W0105010604 LYME ANTIBODY IGM Piyasada OD-399/5ST Czechia 2026-07-11T17:09:56.721Z 48594036043983 B-48594036043983 ELISA-VIDITEST anti-Borelia recombinant IgG + VIsE (CSF) VIDIA spol. s r.o. CZ-MF-000036964 IVD Genel IVDD W0105010603 LYME ANTIBODY IGG Piyasada OD-398/5ST Czechia 2026-07-11T17:09:55.926Z