FDA Registration Active 🇲🇽 Mexico

RPS Adeno Detector, Catalogs: RPS-AD, RPS-DE, FSC-AD, NIC-AD

Reg #: 3009746061 · FEI: 3009746061 · Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Integra Biotechnical, SA de CV
Registration Number
3009746061
FEI Number
3009746061
Status
Active
Expiry Year
2025
Initial Importer
No
Address
Privada Los Pinos #17030 Interior 15, 16, 17, Colonia Ninos Heroes Este, C.P, Ave. Via Rapida Poniente #16835 Interior 3, Centro Ind. Los Pinos II, Colonia Ninos Heroes Este, C.P.
City
Tijuana Baja California
Country
MX

Regulatory Submissions

510(k) Number
K110722

Owner / Operator

Firm Name
Amphenol Critical Medical Technologies, LLC
Operator Number
9030406
Address
9586 Distribution Avenue, Suite F
City
San Diego
State
CA
Postal Code
92121
Country
US
Correspondent
Lamont Rohde

US Agent

Business Name
Amphenol Critical Medical Technologies, LLC
Contact Name
Lamont Rohde
Address
9586 Distribution Avenue, Suite F
City
San Diego
State
CA
ZIP
92121
Country
US
Phone
602 7503539

Products

Device Name Product Code
Antigens, Cf (Including Cf Control), Adenovirus 1-33 GOD

Proprietary Names

RPS Adeno Detector, Catalogs: RPS-AD, RPS-DE, FSC-AD, NIC-AD

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)