FDA Registration Active 🇺🇸 United States

LIAISON Folate Control Set

Reg #: 2182595 · FEI: 2182595 · Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1

Registration Details

Registration Name
DIASORIN INC.
Registration Number
2182595
FEI Number
2182595
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
1951 Northwestern Ave
City
Stillwater
State
MN
ZIP
55082
Country
US

Regulatory Submissions

510(k) Number
K192586

Owner / Operator

Firm Name
DiaSorin Inc.
Operator Number
9051149
Address
1951 Northwestern Ave
City
Stillwater
State
MN
Postal Code
55082
Country
US
Correspondent
Mari Meyer

Products

Device Name Product Code
Acid, Folic, Radioimmunoassay CGN

Proprietary Names

LIAISON Folate Control Set LIAISON Folate Calibration Verifiers LIAISON Folate

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device