FDA Registration Active 🇺🇸 United States

Alinity m Lysis Solution

Reg #: 3025663244 · FEI: 3025663244 · Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1

Registration Details

Registration Name
RPI BIOSOLUTIONS
Registration Number
3025663244
FEI Number
3025663244
Status
Active
Expiry Year
2025
Initial Importer
No
Address
300 TERRACE DR. SUITE A
City
Mundelein
State
IL
ZIP
60060
Country
US

Regulatory Submissions

PMA Number
P210022

Owner / Operator

Firm Name
RPI BIOSOLUTIONS
Operator Number
10086908
Address
300 TERRACE DR. SUITE A
City
Mundelein
State
IL
Postal Code
60060
Country
US

Products

Device Name Product Code
Cytomegalovirus (Cmv) Dna Quantitative Assay PAB

Proprietary Names

Alinity m Lysis Solution Alinity m Diluent Solution

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)