FDA UDI
In Commercial Distribution
🇺🇸 United States
ANTI-MCV
DI: 04260157080539
·
Model: ORG548
·
ORGENTEC Diagnostika GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ANTI-MCV
- Primary DI
- 04260157080539
- Version / Model
- ORG548
- Catalog Number
- ORG548
- Company Name
- ORGENTEC Diagnostika GmbH
- Labeler DUNS
- 328133103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-08
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- d1db33b2-8021-4ce3-8269-25ce72c7afa6
Device Description
Anti-MCV® is an ELISA test system for the qualitative and semi-quantitative measurement of IgG class autoantibodies against mutated citrullinated vimentin (MCV) in human serum or plasma. This product is intended for professional in vitro diagnostic use as an aid in the diagnosis of Rheumatoid Arthritis in conjuction with other laboratory and clinical findings.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| OQZ | Anti-Mutated Citrullinated Vimentin Igg | Immunology | 866.5775 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62473 | Mutated citrullinated vimentin (MCV) antibody 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 antibodies to mutated citrullinated vimentin (MCV) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used in the diagnosis of rheumatoid arthritis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260157080539 | GS1 |
Customer Contacts
- Phone
- +49061319258
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius