FDA UDI
In Commercial Distribution
🇺🇸 United States
ANCA Test System
DI: M7491010011
·
Model: 10100 (1)
·
IMMUNO CONCEPTS INC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ANCA Test System
- Primary DI
- M7491010011
- Version / Model
- 10100 (1)
- Catalog Number
- 10100 (1)
- Company Name
- IMMUNO CONCEPTS INC
- Labeler DUNS
- 038271904
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2025-08-12
- Public Version Status
- Update
- Public Device Record Key
- a0f8dd97-6f6f-4823-887d-68f3c7d6af2f
Device Description
ANCA Sample Diluent 1 x 100mls
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55208 | Multiple thyroid antibody IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple antibodies to the thyroid gland and/or specific products of thyroid gland metabolism in a clinical specimen, using a fluorescent immunoassay method. This test detects autoantibodies directed at antigens such as thyroid gland tissue, thyroglobulin, and thyroid peroxidase (TPO) [known as anti-microsomal antibody] to aid in the diagnosis of autoimmune thyroid diseases such as autoimmune thyroiditis (Hashimoto’s disease) and Graves’ disease. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M7491010011 | HIBCC |