FDA UDI
In Commercial Distribution
🇺🇸 United States
NOVEOS
DI: 00816879022995
·
Model: Immunoassay Analyzer
·
HYCOR BIOMEDICAL LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NOVEOS
- Primary DI
- 00816879022995
- Version / Model
- Immunoassay Analyzer
- Catalog Number
- 63000
- Company Name
- HYCOR BIOMEDICAL LLC
- Labeler DUNS
- 010558476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-08
- Public Version
- 2
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 924cc5bb-e3bc-417f-8fa3-96ef2b0c556c
Device Description
The NOVEOS™ Immunoassay Analyzer is an automated chemiluminescent immunoassay analyzer for measurement of analyte concentration in human specimens. It is intended for in vitro diagnostic use in the clinical laboratory.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Clinical Chemistry | 862.2160 | 1 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | Immunology | 866.5750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56701 | Chemiluminescent immunoassay analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., protein, drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816879022995 | GS1 |
Customer Contacts
- Phone
- 800-382-2527
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182479 | 000 |