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
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

GMDN Terms

Code Name
56701 Chemiluminescent immunoassay analyser IVD

Identifiers

Type ID
Primary 04562185404814

Customer Contacts

Phone
650-615-8134

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
Keep dry and store indoors