FDA.report

PLATE DRY CLI GRAM+ ID AUTO

Primary DI
00848838074325
Brand
PLATE DRY CLI GRAM+ ID AUTO
Company
REMEL, INC.
Model
GNID
Device description
PLATE DRY CLI GRAM+ ID AUTO -A semi-quantitative test intended for the automated identification of Gram negative bacterial isolates based on biochemical reactions. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, the device requires an automated system to produce a result and requires a pure, agar grown culture. This device is for professional use only and is not a companion diagnostic.
Published
2023-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LQMGram Negative Identification Panel

Product Code Classifications

CodeDeviceSpecialtyClass
LQMGram Negative Identification PanelMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00848838074325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838074325008488380743258488380743250848838074325

GMDN Terms

TermDefinition
Multiple aerobic gram positive bacteria species culture isolate identification IVD, kitA collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of aerobic gram positive bacteria that have been isolated by culture from a clinical specimen. Bacteria which may be identified typically belong to the genera Staphylococcus, Enterococcus, or may represent other gram positive cocci and gram positive bacilli genera.

Sterilization Methods

Method

Regulatory Flags

DUNS number
065769564
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00848838031274REMELR40041R400412023-01-03
00842558116709Spectra™ Candida Agar R018332026-02-09
00848838072772MicroTest M6R12582R125822022-12-22
00848838074844MicroTest M4RTR12567R125672022-12-22
00848838075018MicroTest M6R12560R125602022-12-22
00848838091742VersaTREK™ VersaTREK™ Myco Streptomycin, 7120-302025-01-16
00848838003158Strep Selective II AgarR018592026-01-16
00848838059865^BM^ PK/50 OXIDASE TESTR90556352026-01-16
00842558116402BactiSwab Dry PK/100R7231352025-06-19
00848838066665Amies Clear Gel,Single Swab PK/500R7230002025-06-18
00848838066672Amies Clear Gel,Single Swab PK/50R7230052025-06-18
00848838066689Amies Clear Gel,Dual Swab PK/500R7230102025-06-18
00848838066696Amies Clear Gel,Dual Swab PK/50R7230152025-06-18
00848838066702Amies Clear Gel,Wire Shaft Swab PK/100R7230202025-06-18
00848838066719Amies Clear Gel,Wire Shaft PK/50R7230252025-06-18
00848838066757Amies Charcoal Gel,Single Swab PK/50R7230452025-06-18
00848838066856Liquid Amies,Dual Swab PK/50R7230952025-06-18
00848838066887Liquid Stuarts,Single Swab PK/500R7231102025-06-18
00848838066894Liquid Stuarts,Single Swab PK/50R7231152025-06-18
00848838066900Liquid Stuarts,Dual Swab PK/500R7231202025-06-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05032384127917MICROBACT REAGENT SET DOXOID LIMITEDLQM2022-12-07
15099590655402MicroScanBeckman Coulter, Inc.LQM2022-12-05
15099590657239MicroScanBeckman Coulter, Inc.LQM2022-12-05
15099590657321MicroScanBeckman Coulter, Inc.LQM2022-12-05
15099590657604MicroScanBeckman Coulter, Inc.LQM2022-12-05
05032384127955MICROBACT GNB 24E TRAY (40 ID'S)OXOID LIMITEDLQM2022-12-04
05032384127962MICROBACT GNB 12A STRIP (60 ID'S)OXOID LIMITEDLQM2022-12-04
05032384127979MICROBACT GNB 12B STRIP (60 ID'S)OXOID LIMITEDLQM2022-12-04
15099590655181MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655198MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655204MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655211MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655228MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655235MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655242MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655259MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655495MicroscanBeckman Coulter, Inc.LQM2022-11-15
15099590655686MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655709MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655808MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655822MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655846MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655853MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655860MicroScanBeckman Coulter, Inc.LQM2022-11-15
15099590655884MicroScanBeckman Coulter, Inc.LQM2022-11-15
03573026131913VITEK® 2 GNBIOMERIEUX , INC.LQM2020-06-02
15099590733902MicroScanBeckman Coulter, Inc.LQM2019-12-18
15099590733919MicroScanBeckman Coulter, Inc.LQM2019-12-18
00382904480073BD Phoenix™ NIDBECTON, DICKINSON AND COMPANYLQM2018-05-25
30382902450000BD BBL™ Crystal™ Enteric/Nonfermenter BECTON, DICKINSON AND COMPANYLQM2018-05-25