FDA.reportPublic FDA data

Sensititre GP Panel PLATE DRY CLI GRAM+ ID AUTO

Primary DI
00848838074363
Brand
Sensititre GP Panel PLATE DRY CLI GRAM+ ID AUTO
Company
REMEL, INC.
Model
GPID
Device description
PLATE DRY CLI GRAM+ ID AUTO A semi-quantitative test intended for the automated identification of Gram positive 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
Single use
true

Product Codes#

Code, Name table
CodeName
LQLGram Positive Identification Panel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQLGram Positive Identification PanelMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838074363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838074363008488380743638488380743630848838074363

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
065769564
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848838018855NACP114-102016-09-24
00848838031274REMELR40041R400412023-01-03
00842558116709Spectra™ Candida Agar R018332026-02-09
00848838072772MicroTest M6R12582R125822022-12-22
00848838074844MicroTest M4RTR12567R125672022-12-22
00848838075018MicroTest M6R12560R125602022-12-22
00848838091827NA7115-602022-04-21
00848838091742VersaTREK™ VersaTREK™ Myco Streptomycin, 7120-302025-01-16
00848838091834NA7116-702016-12-09
00848838003158Strep Selective II AgarR018592026-01-16
00848838059865^BM^ PK/50 OXIDASE TESTR90556352026-01-16
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
00848838066917Liquid Stuarts,Dual Swab PK/50R7231252025-06-18
00848838066924Liquid Stuarts,Wire Shaft Swab PK/100R7231302025-06-18
00848838066931Liquid Stuarts,Wire Shaft PK/50R7231352025-06-18
00848838011177Sensititre Demineralized WaterT33392023-12-21
00842558105611^CE^Liq Stuarts,Dual Swab 36mmPK/500r97231202025-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590799014MicroScanBeckman Coulter, Inc.LQL2025-12-08
05099590799017MicroScanBeckman Coulter, Inc.LQL2025-12-08
05032384128006Microbact Staph 12SOXOID LIMITEDLQL2024-10-28
05032384128013Microbact Staph Fast Blue ReagentOXOID LIMITEDLQL2024-10-28
15099590657338MicroScanBeckman Coulter, Inc.LQL2022-12-05
15099590657581MicroScanBeckman Coulter, Inc.LQL2022-12-05
05032384127498MICROBACT LISTERIA 12L (20 ID'S)OXOID LIMITEDLQL2022-12-04
03573026529994VITEK® 2 GPBIOMERIEUX , INC.LQL2020-06-02
03573026131920VITEK® 2 GPBIOMERIEUX , INC.LQL2020-06-02
00382904480080BD Phoenix™ PIDBECTON, DICKINSON AND COMPANYLQL2018-05-25
30382902452400BD BBL™ Crystal™ GP Gram-Positive ID SystemBECTON, DICKINSON AND COMPANYLQL2018-05-25
30382902452509BD BBL™ Crystal™ Rapid Gram-Positive ID SystemBECTON, DICKINSON AND COMPANYLQL2018-05-25
30382904480081BD Phoenix™ PIDBECTON, DICKINSON AND COMPANYLQL2018-05-25
00382902450375BD BBL™ Crystal™ ID Systems Gram-Positive Manual CodebookBECTON, DICKINSON AND COMPANYLQL2018-05-25
00382902450412BD BBL™ Crystal™ ID Systems Rapid Gram-Positive Manual CodebookBECTON, DICKINSON AND COMPANYLQL2018-05-25
15099590704025MicroScanBeckman Coulter, Inc.LQL2018-05-11
15099590704032MicroScanBeckman Coulter, Inc.LQL2018-05-11
M578GNID2SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLQL2016-09-24
15099590657376MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657383MicroScan Beckman Coulter, Inc.LQL2016-09-02
15099590657406MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657475MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657499MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657529MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657543MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657567MicroScanBeckman Coulter, Inc.LQL2016-09-02
15099590657574MicroScanBeckman Coulter, Inc.LQL2016-09-02