FDA Registration
Active
🇲🇽 Mexico
ANZA PACKAGING & DISPLAYS DE MEXICO S. DE R.L. DE C.V.
Reg #: 3012516456
·
FEI: 3012516456
·
Expires 2026
Products
8
Proprietary Names
29
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- ANZA PACKAGING & DISPLAYS DE MEXICO S. DE R.L. DE C.V.
- Registration Number
- 3012516456
- FEI Number
- 3012516456
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- CALLE EMILIO FLORES 2471, CANON DEL PADRE
- City
- TIJUANA Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K211342
Owner / Operator
- Firm Name
- ANZA PACKAGING & DISPLAYS DE MEXICO S. DE R.L. DE C.V.
- Operator Number
- 10082574
- Address
- CALLE EMILIO FLORES 2471, CANON DEL PADRE,
- City
- TIJUANA
- State
- Baja California
- Postal Code
- 22230
- Country
- MX
US Agent
- Business Name
- Liberty Management Group Ltd.
- Contact Name
- Manoj Zacharias
- Address
- 75 Executive Drive,, Suite 114,
- City
- Aurora
- State
- IL
- ZIP
- 60504
- Country
- US
- [email protected]
- Phone
- 630 2702921
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2026-04-14 |
| Campylobacter Spp. | LQP | Class 1 | Microbiology | No | 2026-04-14 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2021-08-17 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2022-06-15 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2022-06-15 |
| Electrocardiograph Software For Over-The-Counter Use | QDA | Class 2 | Cardiovascular | No | 2022-06-15 |
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2026-04-15 |
| Antigens, All Groups, Streptococcus Spp. | GTY | Class 1 | Microbiology | No | 2024-11-18 |
Proprietary Names
: QuidelOrtho SOFIA 2 Campylobacter Fluorescent Immunoassay (FIA)
QuidelOrtho SOFIA 2 Campylobacter Fluorescent Immunoassay (FIA)
QuickVue At-Home OTC COVID-19 Test
CareStart COVID-19 Antigen Home Test
for COVID-19 antigen detection tests including CareStart COVID-19 Antigen
on/go COVID-19 Antigen Self-Test
QuickVue At-Home OTC COVID-19 Test 2 pack
QuickVue At-Home OTC COVID-19 Test 25pack
QuidelOrtho QUICKVUE SARS Antigen Test
QuidelOrtho
QuickVue® SARS Antigen Test
QuidelOrtho QUICKVUE HCG URINE 25 TEST KIT (INTL)
QuidelOrtho QUICKVUE HCG COMBO 50 TEST KIT
QuidelOrtho QUICKVUE HCG URINE 25 TEST KIT
QuidelOrtho QKVUE+ HCG SERUM/URINE 30 TEST KIT
QuidelOrtho QKVUE+ HCG SERUM/URINE 90 TEST KIT
KARDIAMOBILE 6L_AliveCor, Inc
QuidelOrtho - QUICKVUE iFOB Test
QuidelOrtho - QuickVue® Influenza A+B Test
Immunoassay Test, Sofia® Strep A FIA
QuidelOrtho - Sofia® Strep A FIA
QuickVue+® Strep A Test
QuidelOrtho - QUICKVUE In-Line Strep A Test
QuidelOrtho SOFIA SARS ANTIGEN 25 TEST KIT (US)
QuidelOrtho -QUICKVUE RSV Test
QuidelOrtho QUICKVUE Dipstick Strep A Test
QuidelOrtho - SOFIA SARS ANTIGEN 25 TEST KIT
QUICKVUE+ Strep A Test
QuidelOrtho - SOFIA 2 C. difficile FIA
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)