Product code LQL
- Device name
- Gram Positive Identification Panel
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2660
- 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 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972576 | GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 | Accumed Intl., Inc. | 1998-01-22 |
| K961730 | RAPID GRAM-POSITIVE ID SYSTEM | Becton Dickinson Microbiology Systems | 1997-02-04 |
| K961968 | BBLCRYSTAL GRAM-POSITIVE ID SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997-02-04 |
| K952095 | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) | Biomerieux Vitek, Inc. | 1996-03-12 |
| K925916 | VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD | Biomerieux Vitek, Inc. | 1993-03-23 |
| K910304 | RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA | Vitek Systems, Inc. | 1991-07-26 |
| K910537 | VISI-STREP | Kev Connecticut Diagnostics, Inc. | 1991-04-12 |
| K901559 | MODIFICATION TO API UNISCEPT 20GP | Analytical Products, Inc. | 1990-09-10 |
| K891004 | RAPIDEC STAPH | Dms Products, Inc. | 1989-11-09 |
| K874606 | CATHRA GRAM POSITIVE SCREEN | Mct Medical, Inc. | 1988-05-06 |
| K863038 | GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL | American Micro Scan | 1986-09-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15099590799014 | MicroScan | Beckman Coulter, Inc. | 2025-12-08 |
| 05099590799017 | MicroScan | Beckman Coulter, Inc. | 2025-12-08 |
| 05032384128006 | Microbact Staph 12S | OXOID LIMITED | 2024-10-28 |
| 05032384128013 | Microbact Staph Fast Blue Reagent | OXOID LIMITED | 2024-10-28 |
| 00848838074363 | Sensititre GP Panel PLATE DRY CLI GRAM+ ID AUTO | REMEL, INC. | 2023-06-20 |
| 15099590657338 | MicroScan | Beckman Coulter, Inc. | 2022-12-05 |
| 15099590657581 | MicroScan | Beckman Coulter, Inc. | 2022-12-05 |
| 05032384127498 | MICROBACT LISTERIA 12L (20 ID'S) | OXOID LIMITED | 2022-12-04 |
| 03573026529994 | VITEK® 2 GP | BIOMERIEUX , INC. | 2020-06-02 |
| 03573026131920 | VITEK® 2 GP | BIOMERIEUX , INC. | 2020-06-02 |
| 30382902452400 | BD BBL™ Crystal™ GP Gram-Positive ID System | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 30382902452509 | BD BBL™ Crystal™ Rapid Gram-Positive ID System | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 30382904480081 | BD Phoenix™ PID | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00382904480080 | BD Phoenix™ PID | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00382902450375 | BD BBL™ Crystal™ ID Systems Gram-Positive Manual Codebook | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 00382902450412 | BD BBL™ Crystal™ ID Systems Rapid Gram-Positive Manual Codebook | BECTON, DICKINSON AND COMPANY | 2018-05-25 |
| 15099590704025 | MicroScan | Beckman Coulter, Inc. | 2018-05-11 |
| 15099590704032 | MicroScan | Beckman Coulter, Inc. | 2018-05-11 |
| M578GNID2 | Sensititre | TREK DIAGNOSTIC SYSTEMS LIMITED | 2016-09-24 |
| 15099590657475 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657499 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657529 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657543 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657567 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657574 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657406 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657383 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |
| 15099590657376 | MicroScan | Beckman Coulter, Inc. | 2016-09-02 |