# K962609: Gram Negative Identification Plus Card

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux Vitek, Inc.
- Decided: Aug 30, 1996 after 58 days
- Product code: LRH (Instrument For Auto Reader Of Overnight Microorganism Identification System)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Gram Negative Identification (GNI) Card: named in the summary without a submission number

## Indications for use
The Vitek GNI+ Card is intended to be used in conjunction with the Vitek System for the automated identification of microorganism of the family Enterobacteriaceae. In addition, a select group of glucose non-fermenting gram-negative bacteria, and members of the family Vibrionaceae can be identified.

Source page: https://510kreport.com/device/K962609
Methodology: https://510kreport.com/methodology