FDA Registration Active 🇺🇸 United States

Molecular

Reg #: 3003030793 · FEI: 3003030793 · Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2

Registration Details

Registration Name
DIAMOND DIAGNOSTICS Inc
Registration Number
3003030793
FEI Number
3003030793
Status
Active
Expiry Year
2025
Initial Importer
No
Address
333 Fiske St
City
Holliston
State
MA
ZIP
01746
Country
US

Regulatory Submissions

510(k) Number
K102740

Owner / Operator

Firm Name
Diamond Diagnostics Inc.
Operator Number
10028706
Address
333 Fiske St
City
Holliston
State
MA
Postal Code
01746
Country
US
Correspondent
Kathy Fisher

Products

Device Name Product Code
Real Time Nucleic Acid Amplification System OOI
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen NQX

Proprietary Names

Molecular

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)