FDA Registration Active 🇺🇸 United States

ORTHO Bovine Albumin Solution Polymerized

Reg #: 2250051 · FEI: 2250051 · Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1

Registration Details

Registration Name
ORTHO-CLINICAL DIAGNOSTICS, INC.
Registration Number
2250051
FEI Number
2250051
Status
Active
Expiry Year
2025
Initial Importer
No
Address
1001 US Highway 202
City
RARITAN
State
NJ
ZIP
08869
Country
US

Owner / Operator

Firm Name
QuidelOrtho Corp.
Operator Number
2024674
Address
9975 Summers Ridge Road, --
City
San Diego
State
CA
Postal Code
92121
Country
US

Products

Device Name Product Code
Albumin, Antigen, Antiserum, Control DCF

Proprietary Names

ORTHO Bovine Albumin Solution Polymerized ORTHO Bovine Serum Albumin, 22% Protein Concentration

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device