eQUANT Reagent - Box of 100

Primary DI
20860007740026
Brand
eQUANT Reagent - Box of 100
Company
AVAILS MEDICAL, INC.
Model
6004
Catalog number
US-EQRTB-100
Device description
eQUANT Reagent - Box of 100
Published
2026-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
QZXPositive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QZXPositive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility TestingMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231536000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231536000eQUANT SystemAvails Medical, Inc.2024-02-08QZX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860007740026PrimaryGS10
00860007740022Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086000774002620860007740026
00860007740022008600077400228600077400220860007740022

GMDN Terms#

Term, Definition table
TermDefinition
General-microorganism antimicrobial susceptibility culture medium IVDA non-selective culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on general microorganisms isolated from a clinical specimen.

Regulatory Flags#

DUNS number
079332405
Device count
100
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
00860007740008eQUANT Instrument1002US-EQINT-0012026-07-23
10860007740012eTube Disposable - Box of 206001US-EQTBE-0202026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007740008eQUANT InstrumentAVAILS MEDICAL, INC.QZX2026-07-23
10860007740012eTube Disposable - Box of 20AVAILS MEDICAL, INC.QZX2026-07-23
00850031114142Selux Seaparator Reagent KitSelux Diagnostics, Inc.QZX2024-12-20
00850031114067PBC Separator with Selux AST SystemSelux Diagnostics, Inc.QZX2024-12-20