FDA.reportPublic FDA data

ASP VIAL

Primary DI
10860008222432
Brand
ASP VIAL
Company
ASP Health Inc.
Model
A-03
Catalog number
PI-0085469
Device description
The ASP VIAL is intended to be used only with the ASP Device, ASP System, and ROSE Prep Pro - DI number: 00860008222404.The ASP VIAL is used to homogenize and dispense the buffer and patient sample into the Sample Pod prior to loading into the device for deposition on to the slide.
Published
2024-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPASlide Stainer, Automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPASlide Stainer, AutomatedPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860008222439PackageGS1960In Commercial Distribution
10860008222432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2086000822243920860008222439
1086000822243210860008222432

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide stainer IVDAn automated mains electricity (AC-powered) laboratory instrument intended to be used to stain blood, tissue and/or other clinical specimens fixed to microscope examination slides, using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
877-527-7432info@asp-health.com

Regulatory Flags#

DUNS number
050200201
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008222404ASP Device; ASP System; ROSE Prep proREV PPI-00765582024-04-05
10860008222418ASP PODA-03PI-00770552024-04-05
20860008222415ASP PODA-03PI-00770552024-04-05
10860008222425ASP HOODA-03PI-00770542024-04-05
20860008222439ASP VIALA-03PI-00854692024-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05700575014420Dako Omnis Waste Accessories (Indirect)AGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-25
05700575000430Dako Omnis 165AGILENT TECHNOLOGIES SINGAPORE PTE LTDKPA2025-06-24
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09349458005665BOND-PRIME automated stainerLEICA BIOSYSTEMS MELBOURNE PTY LTDKPA2024-10-18
05700571107713DakoAGILENT TECHNOLOGIES, INC.KPA2024-08-07
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