FDA UDI
In Commercial Distribution
🇺🇸 United States
ImmunoCAP Specific IgG, Antigen tp, Thyroid Peroxidase
DI: 07333066004013
·
Model: 14-4508-01
·
Phadia AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ImmunoCAP Specific IgG, Antigen tp, Thyroid Peroxidase
- Primary DI
- 07333066004013
- Version / Model
- 14-4508-01
- Catalog Number
- 14-4508-01
- Company Name
- Phadia AB
- Labeler DUNS
- 354019424
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- 0352aab8-8378-4a4d-93bb-cfd48cfa1ae3
Device Description
ImmunoCAP Specific IgG, Antigen tp, Thyroid Peroxidase
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| JZO | SYSTEM, TEST, THYROID AUTOANTIBODY | Immunology | 866.5870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55202 | Thyroid peroxidase antibody (anti-TPO/microsomal 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 antibodies to thyroid peroxidase [anti-TPO, also known as anti-microsomal antibody] in a clinical specimen, using a fluorescent immunoassay method. It is typically used to aid in the diagnosis of chronic lymphocytic thyroiditis (also known as hashimoto thyroiditis). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07333066004020 | GS1 | 3 | In Commercial Distribution | ||
| Primary | 07333066004013 | GS1 |
Customer Contacts
- Phone
- +469999999999
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072661 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius