eQUANT Instrument

Primary DI
00860007740008
Brand
eQUANT Instrument
Company
AVAILS MEDICAL, INC.
Model
1002
Catalog number
US-EQINT-001
Device description
eQUANT Instrument
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
false

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
00860007740008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007740008008600077400088600077400080860007740008

GMDN Terms#

Term, Definition table
TermDefinition
Specimen processing instrument IVDAn electrically-powered instrument or platform intended to be used for the automated or semi-automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data.

Regulatory Flags#

DUNS number
079332405
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
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
10860007740012eTube Disposable - Box of 206001US-EQTBE-0202026-07-23
20860007740026eQUANT Reagent - Box of 1006004US-EQRTB-1002026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10860007740012eTube Disposable - Box of 20AVAILS MEDICAL, INC.QZX2026-07-23
20860007740026eQUANT Reagent - Box of 100AVAILS 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