FDA UDI
In Commercial Distribution
🇺🇸 United States
ADVIA Centaur® FT4
DI: 00630414535425
·
Model: 10282219
·
Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- ADVIA Centaur® FT4
- Primary DI
- 00630414535425
- Version / Model
- 10282219
- Catalog Number
- 6490106
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 064608573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2021-11-18
- Public Version Status
- Update
- Public Device Record Key
- 6ea3c9d6-080c-42c5-933c-b0cd17eae99d
Device Description
Free T4 - CENTAUR - RGT - 250 tests
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| CEC | RADIOIMMUNOASSAY, FREE THYROXINE | Clinical Chemistry | 862.1695 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54413 | Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the quantitative measurement of free thyroxine (FT4) in a clinical specimen, using a chemiluminescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00630414535425 | GS1 | ||||
| Unit of Use | 00630414002910 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store Upright, Protect from Light, Do not freeze, Resuspend.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius