FDA.reportPublic FDA data

Aptiva® System Cleaning Solution Kit

Primary DI
00195126000871
Brand
Aptiva® System Cleaning Solution Kit
Company
INOVA DIAGNOSTICS, INC.
Model
AC1003
Device description
The Aptiva System Cleaning Solution Kit is for use on the Aptiva Multi-Analyte Instrument to clean the instrumentOptical Module (OM) and flush the system.
Published
2024-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NSUInstrumentation For Clinical Multiplex Test Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08430793041140PreviousGS10
00195126000871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
08430793041140084307930411408430793041140
00195126000871001951260008711951260008710195126000871

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/analyser cleaning agent IVDA substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to in vitro diagnostic devices (e.g., analysers, laboratory instruments, other types of laboratory devices) for pre-cleaning and/or cleaning to remove organic compounds such as blood proteins prior to disinfection or sterilization. It is typically loaded on-board automated or semi-automated instruments for internal cleaning. It typically includes a detergent, and some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius20 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-678-0710TechSupport.na@werfen.com

Regulatory Flags#

DUNS number
188354831
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195126001021NOVA Lite® IFA Hu (ANNA-1) Positive Control7040732026-06-09
00195126001038NOVA Lite® IFA Pancreatic Islet Cell Positive Control7040052026-06-09
00195126001045NOVA Lite® IFA Yo (PCA-1) Positive Control7040092026-06-09
08430793040761Aptiva® APS IgG Calibrators7251012024-03-11
08426950514190QUANTA Lite® C1q CIC ELISA7046202026-04-20
08430793041140Aptiva® Optical Cleaning SolutionAC10032024-03-11
08426950454373QUANTA Lite® ANA ELISA7087502016-08-31
08426950456193NOVA Lite® HEp-2 ANA Kit7081002016-08-31
08426950593461NOVA Lite® HEp-2 ANA Kit7081012016-08-31
08426950593577NOVA Lite® ANA Kit with DAPI7081022016-08-31
08426950594208NOVA Lite® HEp-2 External EB Kits7042352016-08-31
08426950594857NOVA Lite® Auto AB Panel 7081802016-08-31
08426950595267NOVA Lite® HEp-2 External EB Kits7042302016-08-31
08430793040181Aptiva® CTD Essential Calibrators7231012023-12-14
08430793040198Aptiva® CTD Essential Controls7231022023-12-14
08426950506324NOVA Lite® ANA KSL Kit7083902016-08-31
08426950514008NOVA Lite® ANA KSL Kit7083802016-08-31
08426950514176NOVA Lite®Rat Liver , Kidney, Stomach Kit7041702016-08-31
08426950545798NOVA Lite®Rat Liver , Kidney, Stomach Kit7041802016-08-31
08426950593539NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach7081502016-08-31

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00840487101971LIAISON PLEX® ModuleLUMINEX CORPORATIONNSU2024-06-20
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