FDA UDI
In Commercial Distribution
🇺🇸 United States
DNA (ds) IgG ELISA
DI: 00840239027740
·
Model: EIA-2774
·
DRG International Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DNA (ds) IgG ELISA
- Primary DI
- 00840239027740
- Version / Model
- EIA-2774
- Catalog Number
- EIA-2774
- Company Name
- DRG International Inc
- Labeler DUNS
- 075150847
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-23
- Public Version
- 1
- Public Version Date
- 2023-08-31
- Public Version Status
- New
- Public Device Record Key
- d731a947-9b54-4568-87a3-16bf9f341e2c
Device Description
The dsDNA ELISA Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to double stranded DNA (dsDNA) in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders.
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 |
|---|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | Immunology | 866.5100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54902 | Double stranded DNA antibody (anti-dsDNA) 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 double stranded DNA (anti-dsDNA) 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 | 00840239027740 | GS1 |
Customer Contacts
- Phone
- 9735647555
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K933267 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius