FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Anti-dsDNA IgM ELISA
DI: 04048474035643
·
Model: EIA-3564
·
DRG Instruments Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Anti-dsDNA IgM ELISA
- Primary DI
- 04048474035643
- Version / Model
- EIA-3564
- Catalog Number
- EIA-3564
- Company Name
- DRG Instruments Gesellschaft mit beschränkter Haftung
- Labeler DUNS
- 317134468
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-10
- Public Version
- 4
- Public Version Date
- 2025-07-14
- Public Version Status
- Update
- Public Device Record Key
- 09d725a4-59bf-4036-83a9-a3a12d0fe0c5
- Distribution End Date
- 2025-07-11
Device Description
Anti-dsDNA IgM ELISA is a test system for the quantitative measurement of IgM class autoantibodies against double-stranded DNA (dsDNA) in human serum or plasma.
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
- No
- 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 |
|---|---|---|---|---|
| LRM | ANTI-DNA ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROL | 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 | 04048474035643 | GS1 |
Customer Contacts
- Phone
- +1(973)564-7555
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius