FDA UDI In Commercial Distribution 🇺🇸 United States

NA

DI: B261CANT342200 · Model: CAN-T3-4220 · Diagnostics Biochem Canada Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
NA
Primary DI
B261CANT342200
Version / Model
CAN-T3-4220
Catalog Number
CAN-T3-4220
Company Name
Diagnostics Biochem Canada Inc
Labeler DUNS
207718438
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-20
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
c9d9f869-2664-4557-a716-c44e2d0b4ff8

Device Description

TRIIODOTHYRONINE (T3) ELISA KIT FOR THE QUANTITATIVE MEASUREMENT OF TRIIODOTHYRONINE IN HUMAN SERUM

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
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
CDP Radioimmunoassay, Total Triiodothyronine

GMDN Terms

Code Name
58332 Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA)

Identifiers

Type ID
Primary B261CANT342200

Customer Contacts

Phone
5192688872

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius