FDA UDI In Commercial Distribution 🇺🇸 United States

hGH-IRMA

DI: 05400569000407 · Model: KIP1081 · Diasource Immunoassays S.A. SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
hGH-IRMA
Primary DI
05400569000407
Version / Model
KIP1081
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
2
Public Version Date
2022-09-16
Public Version Status
Update
Public Device Record Key
a1f8d735-c8ed-4d6a-a722-be6b35a70c25

Device Description

hGH-IRMA

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
CFL RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE

GMDN Terms

Code Name
54218 Human growth hormone (HGH) IVD, kit, radioimmunoassay

Identifiers

Type ID
Primary 05400569000407