FDA UDI
In Commercial Distribution
🇺🇸 United States
ELITe InGenius® Waste Box
DI: 03661540900051
·
Model: F2102-000
·
ELITECHGROUP SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ELITe InGenius® Waste Box
- Primary DI
- 03661540900051
- Version / Model
- F2102-000
- Catalog Number
- F2102-000
- Company Name
- ELITECHGROUP SPA
- Labeler DUNS
- 434528644
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-14
- Public Version
- 1
- Public Version Date
- 2019-02-14
- Public Version Status
- New
- Public Device Record Key
- f0b5e366-bfd7-49a3-9ce2-5689c67f7ef2
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OOI | Real Time Nucleic Acid Amplification System | Clinical Chemistry | 862.2570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62172 | Laboratory waste receptacle IVD | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03661540900051 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180559 | 000 |