FDA UDI
In Commercial Distribution
🇺🇸 United States
Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL300
DI: 04562185404814
·
Model: AIA-CL300
·
TOSOH CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL300
- Primary DI
- 04562185404814
- Version / Model
- AIA-CL300
- Company Name
- TOSOH CORPORATION
- Labeler DUNS
- 690571724
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-14
- Public Version
- 2
- Public Version Date
- 2024-02-09
- Public Version Status
- Update
- Public Device Record Key
- e354f563-4089-4ae2-afb4-c4d4735d4e27
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Clinical Chemistry | 862.2160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56701 | Chemiluminescent immunoassay analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., protein, drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04562185404814 | GS1 |
Customer Contacts
- Phone
- 650-615-8134
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry and store indoors