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
OTC
false
Sterile
false
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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
03573026131920VITEK® 2 GPBIOMERIEUX , INC.LQL2020-06-02
00382904480080BD Phoenix™ PIDBECTON, DICKINSON AND COMPANYLQL2018-05-25
30382902452400BD BBL™ Crystal™ Gram-Positive ID SystBECTON, DICKINSON AND COMPANYLQL2018-05-25
30382902452509BD BBL™ Crystal™ Rapid Gram-Positive IBECTON, 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
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