FDA UDI In Commercial Distribution 🇺🇸 United States

VIDAS® Measles IgG

DI: 03573026064532 · Model: 30219 · BIOMERIEUX SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
VIDAS® Measles IgG
Primary DI
03573026064532
Version / Model
30219
Company Name
BIOMERIEUX SA
Labeler DUNS
276816717
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-08-30
Public Version
1
Public Version Date
2019-09-09
Public Version Status
New
Public Device Record Key
0c8e2c48-f22a-4fc6-8529-e77fbbe6f098

Device Description

VIDAS Measles IgG (MSG) assay is a quantitative IA intended for use on VIDAS family instrument in the detection of IgG antibodies to measles (rubeola) in human serum.

Device Characteristics

Single Use
No
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
LJB Enzyme linked immunoabsorbent assay, rubeola IgG

GMDN Terms

Code Name
49287 Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Identifiers

Type ID
Primary 03573026064532

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius