FDA UDI
In Commercial Distribution
🇺🇸 United States
ORTHO
DI: 10758750033331
·
Model: 6195566
·
ORTHO-CLINICAL DIAGNOSTICS, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ORTHO
- Primary DI
- 10758750033331
- Version / Model
- 6195566
- Catalog Number
- 6195566
- Company Name
- ORTHO-CLINICAL DIAGNOSTICS, INC.
- Labeler DUNS
- 068715424
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-22
- Public Version
- 2
- Public Version Date
- 2023-11-22
- Public Version Status
- Update
- Public Device Record Key
- cb653492-fdf9-4215-8ffc-d394c6981383
Device Description
ORTHO® HCV Version 3.0 ELISA Test System
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48381 | Hepatitis C virus antibody/antigen IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis C virus antigens and antibodies to Hepatitis C virus antigens in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10758750033331 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius