FDA Registration Active 🇦🇷 Argentina

Terragene® Cintape® Chemical Process Indicator Tape (CT40)

Reg #: 3013145340 · FEI: 3013145340 · Expires 2025
Products
2
Proprietary Names
6
Establishment Types
1
Classifications
2

Registration Details

Registration Name
TERRAGENE SA
Registration Number
3013145340
FEI Number
3013145340
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Ruta Nacional No. 9, Km 280, Parque Industrial Micropi
City
Alvear Santa Fe
Country
AR

Regulatory Submissions

510(k) Number
K232103

Owner / Operator

Firm Name
Terragene SA
Operator Number
10056488
Address
Ruta Nacional No 9 km 280,, Parque Industrial Micropi
City
Alvear
State
Santa Fe
Postal Code
2130
Country
AR

US Agent

Business Name
Terragene LLC
Contact Name
Maximiliano Catalano
Address
25003 Pitkin Rd Ste D800
City
Spring
State
TX
ZIP
77386
Country
US
Phone
844 8377243

Products

Device Name Product Code
Indicator, Physical/Chemical Sterilization Process JOJ
A Chemical Vapor Sterilization Multivariable Chemical Indicator QKM

Proprietary Names

Terragene® Cintape® Chemical Process Indicator Tape (CT40) 73250 VERISURE™ VH2O2 Type 4 Multi-Variable Chemical Indicator Strip Terragene® Chemdye® Multivariable Chemical Indicator (CD40) Terragene® Chemdye® Chemical Process Indicator (CD42) 73260 VERISURE™ VH2O2 Type 1 Chemical Indicator Strip 73270 SEALSURE™ VH2O2 Indicator Tape 20mm

Establishment Types

Manufacture Medical Device