eTube Disposable - Box of 20

Primary DI
10860007740012
Brand
eTube Disposable - Box of 20
Company
AVAILS MEDICAL, INC.
Model
6001
Catalog number
US-EQTBE-020
Device description
eTube Disposable - Box of 20
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
10860007740012PrimaryGS10
00860007740015Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000774001210860007740012
00860007740015008600077400158600077400150860007740015

GMDN Terms#

Term, Definition table
TermDefinition
Assay container IVD, single-useA reservoir (e.g., bottle, tube, cup) intended to be used to contain volumes of reagent, buffers, biological specimens, or other materials in preparation for in vitro diagnostic testing procedures performed in the laboratory. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.

Regulatory Flags#

DUNS number
079332405
Device count
20
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
20860007740026eQUANT Reagent - Box of 1006004US-EQRTB-1002026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007740008eQUANT InstrumentAVAILS 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