FDA.reportPublic FDA data

ELITe InGenius® SP 200 Consumable Set

Primary DI
03661540900044
Brand
ELITe InGenius® SP 200 Consumable Set
Company
ELITECHGROUP SPA
Model
INT032CS
Device description
The ELITe InGenius® SP 200 Consumable Set (Catalog number INT032CS) provides consumables to be used with ELITe InGenius® SP 200 (Catalog number INT032SP200) extraction cartridge for nucleic acid extraction from biological samples, in association with the ELITe InGenius® instrument (Catalog number INT030-K). ELITe InGenius system, is a fully automated molecular diagnostics system performing extraction, purification, amplification and detection.ELITe InGenius® SP 200 Consumable Set is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay
Published
2019-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180559000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180559000HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusElitechgroup2018-10-29PGI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540900044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540900044036615409000443661540900044

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid extraction/isolation kit IVDA collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.

Regulatory Flags#

DUNS number
434528644
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540900006ELITe InGenius®INT030-KINT030-K2019-01-09
03661540900051ELITe InGenius® Waste BoxF2102-000F2102-0002019-01-14
03661540900020ELITe InGenius® SP 200INT032SP200INT032SP2002019-01-09
03661540900037ELITe InGenius® PCR cassetteINT035PCRINT035PCR2019-01-10

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