FDA.reportPublic FDA data

ELITe InGenius® Waste Box

Primary DI
03661540900051
Brand
ELITe InGenius® Waste Box
Company
ELITECHGROUP SPA
Model
F2102-000
Catalog number
F2102-000
Device description
The product «ELITe InGenius® Waste Box» (Catalog code F2102-000) provides disposable plastic boxes for collecting tip waste generated during the protocol run for extraction from biological samples, realtime set up in association with the «ELITe InGenius®» a fully automated sample-to-result instrument (Catalog code INT030-K).ELITe InGenius® Waste Box is FDA cleared only for use in association with ELITe InGenius® (Catalog code INT030-K) and HSV1&2 ELITe MGB® Assay.
Published
2019-01-14
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
03661540900051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540900051036615409000513661540900051

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory waste receptacle IVDA non-sterile container intended to collect and contain disposable materials/devices that have been contaminated due to contact with bodily fluids/substances (e.g., blood, sputum, urine, faeces) resulting from in vitro diagnostic procedures. It is typically in the form of a sack, box, or bottle made of durable plastic impervious to microorganisms. It may be used to collect solid and/or liquid waste from a laboratory instrument or analyser. This is a single-use device intended to be disposed of with its contents.

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
03661540900020ELITe InGenius® SP 200INT032SP200INT032SP2002019-01-09
03661540900037ELITe InGenius® PCR cassetteINT035PCRINT035PCR2019-01-10
03661540900044ELITe InGenius® SP 200 Consumable Set INT032CS2019-01-10

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