FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ImmunoWELL Cardiolipin (IgM) Test
DI: 00613745031002
·
Model: 800-3100
·
GenBio
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- ImmunoWELL Cardiolipin (IgM) Test
- Primary DI
- 00613745031002
- Version / Model
- 800-3100
- Catalog Number
- 3100
- Company Name
- GenBio
- Labeler DUNS
- 940425333
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2026-04-20
- Public Version Status
- Update
- Public Device Record Key
- 4eb67405-22f4-465b-88bf-c9ea6b26fb16
- Distribution End Date
- 2025-08-28
Device Description
The ImmunoWELL Cardiolipin Antibody (IgM) Test is an enzyme immunoassay (EIA) for the quantitative detection of antibodies to cardiolipin antigen in serum and is used as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| MID | System, Test, Anticardiolipin Immunological | Immunology | 866.5660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54870 | Anticardiolipin 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 one or multiple classes of antibodies to cardiolipin 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 | 00613745031002 | GS1 |
Customer Contacts
- Phone
- 858-592-9300
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 96 tests |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius