Singapore HSA registration DE0013232

bioMerieux VITEK 2 Antimicrobial Automated Susceptibility Test

Singapore·CLASS B IVD·bioMérieux Inc·Registered June 25, 2013

Device classification

Device Class: CLASS B IVD
Medical Speciality Area: Microbiology

Registration information

Registration Number: DE0013232
Registration Date: June 25, 2013
Change Notification Approval Date: January 20, 2025
Retention Due Date: June 24, 2025

Product description

These reagents are used to test the susceptibility of most bacteria aerobic organisms, anaerobic organisms, Gram-negative bacilli, Gram-positive organisms, fastidious organisms, clinically significant yeasts and yeast-like organisms.

Product Owner

Name: bioMérieux Inc
Short Name: bioMérieux Inc
Address: 100 Rodolphe Street, Durham,, North Carolina 27712, UNITED STATES

Registrant

Name: BIOMERIEUX SINGAPORE PTE. LTD.
Address: 11 BIOPOLIS WAY, HELIOS, #10-03, SINGAPORE 138667

Importer

Name: BIOMERIEUX SINGAPORE PTE. LTD.
Address: 11 BIOPOLIS WAY, HELIOS, #10-04, SINGAPORE 138667

Model information

Model Name(s): DENSICHEK Plus Instrument kit DENSICHEK Plus Standard kit AST-P576 AST-GP67 AST-GP68 AST-P580 AST-P584 AST-P586 AST-P592 AST-P612 AST-ST01 AST-GP71 AST-GP72 AST-YS05 AST-N203 AST-N204 AST-N214 AST-N215 AST-N222 AST-N223 AST-N232 AST-N233 AST-N235 AST-N240 AST-XN05 AST-N247 AST-GN66 AST-GN67 AST-GN69 AST-GN70 AST-GN71 AST-GN72 AST-GN73 AST-GN84 AST-GN68 AST-GN75 AST-GN76 AST-GN77 AST-GN78 AST-GN-79 AST-GN80 AST-GN81 AST - GN82 AST-GN83 AST-N257 AST-GN74 AST-GN86 AST-GN87 AST-XN06 AST-N275 AST-GN89 AST-GN90 AST-GN91 AST-GN92 AST-GP74 AST-GN93 AST-GP75 AST-N315 Vitek 2 0.45% Sodium Chloride Diluent AST-YS08 AST-ST03 AST-N356 VITEK® 2 AST-N414 VITEK® 2 AST-N415 VITEK® 2 AST-N423 VITEK® 2 AST-N443 Test a la Bacitracine (BAC-F), Bacitracin Test Test a l'optochine (OPTO-F), Optochin Test DENSICHEK Calibrator Standard
Model Identifier(s): 21250 21255 22216 22226 22231 22233 22252 22276 22287 22359 410028 410750 410770 411945 412864 412865 413064 413065 413083 413110 413116 413117 413170 413205 413230 413396 413398 413399 413400 413401 413402 413403 413404 413410 413431 413432 413433 413434 413435 413436 413437 413438 413439 413440 413726 413941 413942 413943 413944 414313 414367 414779 414780 414963 414971 414985 415670 417426 417820 420739 421040 421352 423933 423934 424042 424541 55902 55912 93059

About this record

Access comprehensive regulatory information for bioMerieux VITEK 2 Antimicrobial Automated Susceptibility Test in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0013232 and owned by bioMérieux Inc. The device was registered on June 25, 2013.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD