FDA UDI Not in Commercial Distribution 🇺🇸 United States

IFA: Legionella Mosaic 4 (IgG)

DI: 04049016089520 · Model: FI 2150-1010-4 G · EUROIMMUN Medizinische Labordiagnostika AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
IFA: Legionella Mosaic 4 (IgG)
Primary DI
04049016089520
Version / Model
FI 2150-1010-4 G
Company Name
EUROIMMUN Medizinische Labordiagnostika AG
Labeler DUNS
322209263
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-10-10
Public Version
3
Public Version Date
2022-07-21
Public Version Status
Update
Public Device Record Key
487737e3-8f7d-4509-ad64-9e12c1172e0c
Distribution End Date
2022-05-27

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

GMDN Terms

Code Name
62353 Multiple Legionella species immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Identifiers

Type ID
Primary 04049016089520

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 8 Degrees Celsius