FDA UDI
In Commercial Distribution
🇺🇸 United States
Thermo Scientific Infinity™ for Beckman Coulter AU® Chemistry Analyzers
DI: 00845275004526
·
Model: 106517
·
Fisher Diagnostics
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- Thermo Scientific Infinity™ for Beckman Coulter AU® Chemistry Analyzers
- Primary DI
- 00845275004526
- Version / Model
- 106517
- Company Name
- Fisher Diagnostics
- Labeler DUNS
- 183998769
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 40d27ea0-1c4c-409c-b062-cb3b18da33f7
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 |
|---|---|---|---|---|
| NDW | Assay, Porphyrin, Spectrophotometry, Lithium | Clinical Toxicology | 862.3560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55405 | Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy | A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug lithium in a clinical specimen, using an atomic spectroscopy method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845275004526 | GS1 | ||||
| Unit of Use | 00845275005912 | GS1 |
Customer Contacts
- Phone
- 800-528-0494
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K003583 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from Light
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius