Product code LON
- Device name
- System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.1645
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P870049S032 | MICROSCAN RAPID GRAM POSITIVE FLUOROGENIC PANELS | Dade Intl., Inc. | 2001-11-30 |
| P870049S031 | MICROSCAN RAPID FLUOROGENIC PANELS | Dade Intl., Inc. | 2001-11-09 |
| P870049S030 | MICROSCAN(R) RAPID FLUOROGENIC PANELS | Dade Intl., Inc. | 2000-06-05 |
| P870049S029 | MICROSCAN RAPID FLUOROGENIC PANELS | Dade Intl., Inc. | 1999-06-24 |
| P870049S028 | MICROSCAN RAPID FLUOROGENIC PANELS | Dade Intl., Inc. | 1999-01-25 |
| P870049S027 | MICROSCAN(R) RAPID FLUOROGENIC PANELS | Dade Intl., Inc. | 1998-06-30 |
| P870049S025 | MICROSCAN (R) RAPID FLUOROGENIC PANELS-GENTAMICIN GRAM NEGATIVE PANELS | Dade Intl., Inc. | 1996-05-03 |
| P870049S024 | MICROSCAN RAPID FLUOROGENIC PANELS | Dade Intl., Inc. | 1996-03-12 |
| P870049S023 | MICROSCAN RAPID FLUOROGENIC PANELS | Dade Intl., Inc. | 1995-05-05 |
| P870049S022 | MICROSCAN RAPID FLUOROGENIC PANELS | Dade Intl., Inc. | 1994-12-08 |
| P870049S021 | MICROSCAN RAPID FLUOROGENIC PANELS | Dade Intl., Inc. | 1994-10-04 |
| P870049S018 | RAPID POSITIVE MIC PANEL | Dade Intl., Inc. | 1994-05-09 |
| P870049S020 | MICROSCAN RAPID FLUOROGENIC PANELS | Dade Intl., Inc. | 1994-02-10 |
| P870049S014 | MICROSCAN(R) | Dade Intl., Inc. | 1993-03-12 |
| P870049S016 | MICROSCAN(R)ALANINE-AMC R GRAM NEG.MIC PANELS | Dade Intl., Inc. | 1992-02-28 |
| P870049S015 | MICROSCAN(R)ALANINE-AMC R GRAM NEG.MIC PANELS | Dade Intl., Inc. | 1991-12-18 |
| P870049S013 | MICROSCAN(R) | Dade Intl., Inc. | 1991-11-06 |
| P870049S012 | MICROSCAN(R) | Dade Intl., Inc. | 1991-11-06 |
| P870049S011 | MICROSCAN(R) WALKAWAY(TM)-40 | Dade Intl., Inc. | 1991-11-06 |
| P870049S010 | MICROSCAN RAPID FLUOROGENIC PANELS | Dade Intl., Inc. | 1991-01-08 |
| P870049S009 | MICROSCAN RAPID FLUOROGENIC PANELS | Dade Intl., Inc. | 1991-01-08 |
| P870049S008 | MICROSCAN RAPID FLUOROGENIC PANELS | Dade Intl., Inc. | 1990-12-20 |
| P870049S005 | MICROSCAN RAPID FLUOROGENIC PANELS | Dade Intl., Inc. | 1990-08-03 |
| N50525S026 | ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM | Abbott Laboratories | 1990-05-04 |
| P870049S004 | MICROSCAN RAPID FLUOROGENIC PANELS | Dade Intl., Inc. | 1990-01-22 |
| N50524S033 | AUTOBAC MIC TEST SYSTEM | Organon Teknika Corp. | 1990-01-22 |
| N50525S025 | ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM | Abbott Laboratories | 1989-12-19 |
| N50524S035 | AUTOBAC MIC TEST SYSTEM | Organon Teknika Corp. | 1989-12-07 |
| N50525S023 | ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM | Abbott Laboratories | 1989-11-16 |
| P870049S003 | MICROSCAN RAPID FLUOROGENIC PANELS | Dade Intl., Inc. | 1989-10-03 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | bioMerieux, Inc. | 2026-04-15 |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (=8 µg/mL) | BIOMERIEUX | 2026-03-26 |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=32 µg/mL) | bioMerieux, Inc. | 2025-08-21 |
| K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) | Becton, Dickinson and Company | 2025-08-08 |
| K250447 | BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) | Becton, Dickinson and Company | 2025-05-19 |
| K234012 | VITEK COMPACT PRO | bioMerieux, Inc. | 2025-03-14 |
| K250344 | BD Phoenix™ Automated Microbiology System | Becton, Dickinson and Company | 2025-03-06 |
| K233986 | BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) | Becton, Dickinson and Company | 2024-03-15 |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (=4 µg/mL) | bioMerieux, Inc. | 2024-03-11 |
| K232756 | Colibrí | Copan Wasp Srl | 2023-12-27 |
| K232201 | VITEK 2 AST-Streptococcus Penicillin (8 µg/mL), VITEK 2 Streptococcus Penicillin (=8 µg/mL), VITEK 2 Streptococcus Penicillin | bioMerieux, Inc. | 2023-10-23 |
| K230864 | VITEK 2 AST-Gram Positive Daptomycin (=8 µg/mL), VITEK 2 AST-GP Daptomycin (=8 µg/mL), VITEK 2 AST-GP Daptomycin | bioMerieux, Inc. | 2023-07-05 |
| K222378 | VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL) | bioMerieux, Inc. | 2023-06-26 |
| K211748 | Selux AST System; Model AST Gen 1.0 | Selux Diagnostics, Inc. | 2023-04-19 |
| K222430 | VITEK 2 AST-Gram Negative Fosfomycin (=256 µg/mL), VITEK 2 AST-GN Fosfomycin (=256 µg/mL), VITEK 2 AST-GN Fosfomycin | Biomerieux Sa, Inc. | 2023-03-09 |
| K223478 | VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin | bioMerieux, Inc. | 2023-02-16 |
| K222073 | VITEK 2 AST-Gram Negative Cefazolin (=32 ug/mL) | bioMerieux, Inc. | 2023-02-09 |
| K223481 | VITEK® 2 Streptococcus Tetracycline (=16 µg/mL) | bioMerieux, Inc. | 2023-02-03 |
| K220803 | VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin | bioMerieux, Inc. | 2023-01-27 |
| K211759 | Selux AST System; Model AST Gen 1.0 | Selux Diagnostics, Inc. | 2023-01-18 |
| K220805 | VITEK 2 AST-Gram Positive Cefoxitin Screen | bioMerieux, Inc. | 2022-10-13 |
| K220546 | Colibrí System | Copan Wasp Srl | 2022-10-05 |
| K212243 | VITEK 2 AST- Gram Positive Telavancin (=1 µg/mL) | bioMerieux, Inc. | 2022-08-08 |
| K213899 | VITEK 2 AST-Yeast Caspofungin (=8 µg/mL), VITEK 2 AST-YS Caspofungin (=8 µg/mL), VITEK 2 AST-YS Caspofungin | bioMerieux, Inc. | 2022-07-12 |
| K213931 | VITEK 2 AST-Gram Negative Omadacycline (=16 µg/mL) | bioMerieux, Inc. | 2022-06-03 |
| K214023 | VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL) | bioMerieux, Inc. | 2022-04-14 |
| K213241 | VITEK 2 AST-Yeast Fluconazole (=64 µg/mL), VITEK 2 AST-YS Fluconazole (=64 µg/mL), VITEK 2 AST-YS Fluconazole | bioMerieux, Inc. | 2022-02-25 |
| K212849 | VITEK 2 AST-Gram Positive Linezolid (=8 µg/mL) | Biomérieux, Inc. | 2022-02-04 |
| K210287 | VITEK 2 AST- Streptococcus Cefotaxime (8 ug/mL) | bioMerieux, Inc. | 2021-10-28 |
| K202396 | VITEK 2 AST-Gram Positive Fosfomycin (=256 ug/mL) | bioMerieux, Inc. | 2021-09-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 30382904490851 | NMIC-315 | BECTON, DICKINSON AND COMPANY | 2026-01-29 |
| 00860012092116 | LSGN | Affinity Biosensors, LLC | 2025-10-14 |
| 00860012092109 | LifeScale AST | Affinity Biosensors, LLC | 2025-10-14 |
| 30382904490837 | NMIC/ID-313 | BECTON, DICKINSON AND COMPANY | 2025-03-20 |
| 30382904490820 | NMIC-312 | BECTON, DICKINSON AND COMPANY | 2025-03-20 |
| 00850031114005 | Bulk Analyzer Reagent Pack | Selux Diagnostics, Inc. | 2024-12-20 |
| 00195893563760 | Selux AST System | Selux Diagnostics, Inc. | 2024-12-20 |
| 00850031114029 | Selux AST Gram Negative Panel | Selux Diagnostics, Inc. | 2024-12-20 |
| 00850031114142 | Selux Seaparator Reagent Kit | Selux Diagnostics, Inc. | 2024-12-20 |
| 30382904490363 | Panel Phoenix PMIC-110 | BECTON, DICKINSON AND COMPANY | 2024-08-29 |
| 30382904494521 | BD Phoenix™ NMIC-311 | BECTON, DICKINSON AND COMPANY | 2024-08-29 |
| 18052870817966 | Colibrí™ Primary Tube with Saline | COPAN WASP SRL | 2024-01-31 |
| 18050148217975 | Colibrí™ Primary Tube with Water | COPAN WASP SRL | 2024-01-31 |
| 30382904492824 | BD Phoenix™ NMIC/ID-308 | BECTON, DICKINSON AND COMPANY | 2023-10-24 |
| 30382904492831 | BD Phoenix™ NMIC-307 | BECTON, DICKINSON AND COMPANY | 2023-10-24 |
| 30382904492947 | BD Phoenix™ NMIC-305 | BECTON, DICKINSON AND COMPANY | 2023-10-24 |
| 30382904492923 | BD Phoenix™ NMIC-306 | BECTON, DICKINSON AND COMPANY | 2023-10-24 |
| 58052870818428 | Colibrí™ Vision System | COPAN WASP SRL | 2022-01-27 |
| 58052870816202 | Colibrí™ System | COPAN WASP SRL | 2022-01-27 |
| 30382902460153 | BD Phoenix™ Emerge™ AST Indicator Solution | BECTON, DICKINSON AND COMPANY | 2021-02-15 |
| 30382902460160 | BD Phoenix™ Emerge™ AST Broth | BECTON, DICKINSON AND COMPANY | 2021-02-15 |
| 30382904492893 | BD Phoenix™ NMIC/ID-307 | BECTON, DICKINSON AND COMPANY | 2020-02-19 |
| 30382904490653 | BD Phoenix™ NMIC-308 | BECTON, DICKINSON AND COMPANY | 2020-02-19 |
| 15099590733926 | MicroScan | Beckman Coulter, Inc. | 2019-12-18 |
| 15099590731144 | MicroScan | Beckman Coulter, Inc. | 2019-09-04 |
| 15099590703271 | MicroScan | Beckman Coulter, Inc. | 2018-07-06 |
| 15099590676872 | MicroScan | Beckman Coulter, Inc. | 2016-09-23 |
| 15099590676889 | MicroScan | Beckman Coulter, Inc. | 2016-09-23 |
| 07613327170566 | VertaPlex | STRYKER CORPORATION | 2016-09-23 |
| 07613327170559 | VertaPlex HV | STRYKER CORPORATION | 2016-09-23 |