FDA UDI
In Commercial Distribution
🇺🇸 United States
ORTHO
DI: 10758750013265
·
Model: 5561701
·
ORTHO-CLINICAL DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ORTHO
- Primary DI
- 10758750013265
- Version / Model
- 5561701
- Catalog Number
- 5561701
- Company Name
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Labeler DUNS
- 068715424
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-24
- Public Version
- 5
- Public Version Date
- 2023-06-21
- Public Version Status
- Update
- Public Device Record Key
- 1bc30c79-8d3c-4dd1-9278-d23c217687fc
Device Description
ORTHO VERSEIA™ Pipetter
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56718 | Enzyme immunoassay (EIA) 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, in a clinical specimen, using an immunological method which utilizes an enzyme-based detection system with sample processing, data processing and/or data display software. It uses enzyme-labelled antigens or antibodies and a solid-phase binding support (e.g., beads, microplates) to measure the substance of interest, typically antigens, antibodies, drugs, or endogenous substances in body fluids. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10758750013265 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -15 – 45 Degrees Celsius