FDA UDI In Commercial Distribution 🇺🇸 United States

DHEA-S-RIA-CT

DI: 05400569000353 · Model: KIP0481 · Diasource Immunoassays S.A. SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DHEA-S-RIA-CT
Primary DI
05400569000353
Version / Model
KIP0481
Company Name
Diasource Immunoassays S.A. SA
Labeler DUNS
458777323
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-01-15
Public Version
1
Public Version Date
2020-01-23
Public Version Status
New
Public Device Record Key
35559710-82d4-4349-bffd-a5f17a1fa088

Device Description

DHEA-S-RIA-CT

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
Yes
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JKC RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)

GMDN Terms

Code Name
54139 Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay

Identifiers

Type ID
Primary 05400569000353