FDA UDI
Not in Commercial Distribution
🇺🇸 United States
IMMULITE®/IMMULITE® 1000 Systems ATA Anti -TPO Ab
DI: 00630414964744
·
Model: 10381618
·
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IMMULITE®/IMMULITE® 1000 Systems ATA Anti -TPO Ab
- Primary DI
- 00630414964744
- Version / Model
- 10381618
- Catalog Number
- LKTO1
- Company Name
- SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- Labeler DUNS
- 296822794
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 7
- Public Version Date
- 2025-10-16
- Public Version Status
- Update
- Public Device Record Key
- 6a6628b6-872c-4f1d-9a1b-7df97cabd452
- Distribution End Date
- 2025-09-30
Device Description
TPO Ab - IMMULITE - RGT - 100 Tests
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 58729 | Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent 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 chemiluminescent 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 |
|---|---|---|---|---|---|---|
| Primary | 00630414964744 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K963695 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius