FDA UDI In Commercial Distribution 🇺🇸 United States

Free Thyroxine (fT4) ELISA

DI: 00840239042668 · Model: EIA-4266 · DRG International Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Free Thyroxine (fT4) ELISA
Primary DI
00840239042668
Version / Model
EIA-4266
Catalog Number
EIA-4266
Company Name
DRG International Inc
Labeler DUNS
075150847
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-06-10
Public Version
3
Public Version Date
2023-07-26
Public Version Status
Update
Public Device Record Key
6df86ddd-67d8-4a0b-a6c7-2ef5fa4cc914

Device Description

The Quantitative Determination of Free Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay.

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
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
CEC RADIOIMMUNOASSAY, FREE THYROXINE

GMDN Terms

Code Name
54412 Free thyroxine (FT4) IVD, kit, enzyme immunoassay (EIA)

Identifiers

Type ID
Primary 00840239042668

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius