FDA.reportPublic FDA data

illumipro-10

Primary DI
00840733101243
Brand
illumipro-10
Company
MERIDIAN BIOSCIENCE, INC.
Model
610172
Catalog number
610172
Device description
The illumipro-10 is an automated isothermal amplification and detection system for use with Meridian Bioscience, Inc. illumigene Loop-Mediated Amplification products.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840733101243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840733101243008407331012438407331012430840733101243

GMDN Terms#

Term, Definition table
TermDefinition
Isothermal nucleic acid amplification analyser IVD, laboratory, automatedA mains electricity (AC-powered) laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen at a constant (isothermal) temperature, using a series of transcription and reverse transcription reactions, and to detect and/or identify the amplified product using oligonucleotide markers as it is produced (i.e., in real-time). The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
513-271-3700info@meridianbioscience.com
800-343-3858MBI-TechService@meridianbioscience.com

Regulatory Flags#

DUNS number
092815364
Device count
1
Kit
true
Serial number
true

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