Etest® QUINUPRI/DALFO

Primary DI
03573026378530
Brand
Etest® QUINUPRI/DALFO
Company
BIOMERIEUX SA
Model
Etest® QUINUPRI/DALFO
Device description
Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.
Published
2018-11-14
Public version status
Update
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
LTXDISCS, ELUTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LTXDiscs, ElutionMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992993000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992993000ETEST FOR QUINUPRISTIN/DALFOPRISTINAb Biodisk1999-11-16LTX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026378530PackageGS130In Commercial Distribution
03573026550417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026378530035730263785303573026378530
03573026550417035730265504173573026550417

GMDN Terms#

Term, Definition table
TermDefinition
Antibacterial minimum inhibitory concentration (MIC) IVDA graduated test strip or collection of reagents containing a specified concentration gradient of a specific antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection, excluding mycobacterial infection) intended to be used to determine the minimum inhibitory concentration (MIC) for a particular microorganism, isolated from a clinical specimen by culture.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius8 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
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
03573026547196ETEST® Fosfomycin (FM)ETEST® Fosfomycin (FM)2016-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.LTX2026-04-16
03573026620110ETEST® Linezolid (LZ)BIOMERIEUX SALTX2021-07-13
03573026619671ETEST®BIOMERIEUX SALTX2021-07-13
03573026550417ETEST® Quinupristin/Dalfopristin (QDA)BIOMERIEUX SALTX2018-11-14
03573026550479ETEST® Linezolid (LZ)BIOMERIEUX SALTX2016-12-12
03573026378097Etest® LINEZOLIDBIOMERIEUX SALTX2016-12-12
03573026549145Etest® QUINUPRI/DALFOBIOMERIEUX SALTX2016-11-18
03573026549206ETEST® Linezolid (LZ)BIOMERIEUX SALTX2016-11-18
03573026253479Etest® QUINUPRI/DALFOBIOMERIEUX SALTX2016-11-18
03573026253677Etest® LINEZOLIDBIOMERIEUX SALTX2016-11-18