FDA.reportPublic FDA data

SALINE SOLUTION

Primary DI
03573026617943
Brand
SALINE SOLUTION
Company
BIOMERIEUX SA
Model
SALINE SOLUTION
Device description
Saline Solution is a diluent used for manual preparation of organism suspensions, prior to identification and antimicrobial susceptibility processing with VITEK® 2 instruments.
Published
2022-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Product Codes#

Code, Name table
CodeName
LTWSusceptibility test cards, antimicrobial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LTWSusceptibility Test Cards, AntimicrobialMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
N50510000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
N50510000VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARDBiomerieux Vitek, Inc.1978-03-02LTW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026617943PackageGS112In Commercial Distribution
03573026617936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026617943035730266179433573026617943
03573026617936035730266179363573026617936

GMDN Terms#

Term, Definition table
TermDefinition
Sterile saline suspension medium/diluent IVDA sterile saline solution intended to be used as a non-enriching diluent or suspension medium for microorganisms isolated from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276816717
Device count
1
DM exempt
false
Premarket exempt
false
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
03573026546984Etest® MEROPENEMEtest® MEROPENEM2016-11-18
03573026064532VIDAS® Measles IgG302192019-08-30
03573026064518VIDAS® Varicella-Zoster IgG302172016-08-31
03573026610418VITEK®MSVITEKMS SW v1.0 / FlexPrep v1.02019-04-30
03573026644796VIDAS® Varicella-Zoster IgG30217-012026-01-19
03573026550523ETEST® Tigecycline (TGC)Etest® TIGECYCLINE2016-12-12
03573026584139ID color CatalaseID color Catalase2019-07-19
03573026092009ID color CatalaseID color Catalase2019-07-19
03573026559823THxID™ BRAF1.02017-05-12
03573026121631VIDAS® Quality Control307062019-11-19
B0744000160ASTUTE140 Electronic Quality Control (EQC) Device4000164000162016-08-12
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) Kit5000095000092016-08-12
B0745000110NEPHROCHECK Test Kit 5000115000112016-08-12
B0745000130NEPHROCHECK Liquid Control Kit5000135000132016-08-12
03573026547226ETEST® Ertapenem (ETP)ETEST® Ertapenem (ETP)2016-11-18
03573026547271ETEST® Tobramycin (TM)ETEST® Tobramycin (TM)2016-11-18
03573026547295ETEST® Tigecycline (TGC)ETEST® Tigecycline (TGC)2016-11-18
03573026548674ETEST® Ampicillin/sulbactam (2/1) (AB)ETEST® Ampicillin/sulbactam (2/1) (AB)2016-11-18
03573026549046ETEST® Tetracycline (TC)ETEST® Tetracycline (TC)2016-11-18
03573026549077ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)2016-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590798970MicroScanBeckman Coulter, Inc.LTW2025-12-08
15099590798987MicroScanBeckman Coulter, Inc.LTW2025-12-08
15099590798994MicroScanBeckman Coulter, Inc.LTW2025-12-08
15099590799007MicroScanBeckman Coulter, Inc.LTW2025-12-08
15099590799014MicroScanBeckman Coulter, Inc.LTW2025-12-08
15099590799021MicroScanBeckman Coulter, Inc.LTW2025-12-08
05032384500406SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLTW2025-04-11
00850031114029Selux AST Gram Negative PanelSelux Diagnostics, Inc.LTW2024-12-20
00850031114142Selux Seaparator Reagent KitSelux Diagnostics, Inc.LTW2024-12-20
00195893563760Selux AST SystemSelux Diagnostics, Inc.LTW2024-12-20
00850031114005Bulk Analyzer Reagent PackSelux Diagnostics, Inc.LTW2024-12-20
00850031114036AST InoculatorSelux Diagnostics, Inc.LTW2024-12-20
00850031114043AST AnalyzerSelux Diagnostics, Inc.LTW2024-12-20
00850031114067PBC Separator with Selux AST SystemSelux Diagnostics, Inc.LTW2024-12-20
00850031114135Selux AST Gram Positive PanelsSelux Diagnostics, Inc.LTW2024-12-17
05032384512621SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLTW2024-07-24
05032384571369SensititreTREK DIAGNOSTIC SYSTEMS LIMITEDLTW2024-07-24
15099590765361MicroScanBeckman Coulter, Inc.LTW2022-08-01
15099590765378MicroScanBeckman Coulter, Inc.LTW2022-08-01
15099590765385MicroScanBeckman Coulter, Inc.LTW2022-08-01
03573026628116VITEK® 2 AST-XN19BIOMERIEUX , INC.LTW2022-04-15
03573026617936SALINE SOLUTIONBIOMERIEUX SALTW2022-02-10
03573026617950SALINE SOLUTIONBIOMERIEUX SALTW2022-02-10
03573026556969VITEK® 2 0,45% Sodium Chloride DiluentBIOMERIEUX , INC.LTW2020-09-30
15099590733902MicroScanBeckman Coulter, Inc.LTW2019-12-18
15099590733919MicroScanBeckman Coulter, Inc.LTW2019-12-18
15099590731212MicroScanBeckman Coulter, Inc.LTW2019-09-04
15099590704025MicroScanBeckman Coulter, Inc.LTW2018-05-11
15099590704032MicroScanBeckman Coulter, Inc.LTW2018-05-11
15099590704049MicroScanBeckman Coulter, Inc.LTW2018-05-11