Gram Positive Identification Panel
The Gram Positive Identification Panel is an in vitro diagnostic device consisting of a panel of biochemical substrates used to identify gram-positive bacteria from clinical cultures based on their metabolic reaction profiles. It is classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LQL, regulated under 21 CFR 866.2660, within the Microbiology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LQL
- Device Class
- FDA class 1
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K972576 | GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 | Jan 22, 1998 | Substantially Equivalent | Accumed Intl., Inc. |
| K961968 | BBLCRYSTAL GRAM-POSITIVE ID SYSTEM | Feb 04, 1997 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K961730 | RAPID GRAM-POSITIVE ID SYSTEM | Feb 04, 1997 | Substantially Equivalent | Becton Dickinson Microbiology Systems |
| K952095 | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) | Mar 12, 1996 | Substantially Equivalent | Biomerieux Vitek, Inc. |
| K925916 | VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD | Mar 23, 1993 | Substantially Equivalent | Biomerieux Vitek, Inc. |
| K910304 | RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA | Jul 26, 1991 | Substantially Equivalent | Vitek Systems, Inc. |
| K910537 | VISI-STREP | Apr 12, 1991 | Substantially Equivalent | Kev Connecticut Diagnostics, Inc. |
| K901559 | MODIFICATION TO API UNISCEPT 20GP | Sep 10, 1990 | Substantially Equivalent | Analytical Products, Inc. |
| K891004 | RAPIDEC STAPH | Nov 09, 1989 | Substantially Equivalent | Dms Products, Inc. |
| K874606 | CATHRA GRAM POSITIVE SCREEN | May 06, 1988 | Substantially Equivalent | Mct Medical, Inc. |
| K863038 | GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL | Sep 30, 1986 | Substantially Equivalent | American Micro Scan |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.