Data / Medical devices / Mexico / Anza Packaging & Displays De Mexico S. De R.L. De C.V.
Anza Packaging & Displays De Mexico S. De R.L. De C.V.: FDA-registered device maker in TIJUANA Baja California, Mexico, 5 510(k) clearances
Anza Packaging & Displays De Mexico S. De R.L. De C.V. is registered with the FDA (registration 3012516456) in TIJUANA Baja California, Mexico. It lists 11 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 23, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012516456
- Address
- Calle Emilio Flores 2471, Canon Del Padre, TIJUANA Baja California, Mexico, 22230
- Owner or operator
- ANZA PACKAGING & DISPLAYS DE MEXICO S. DE R.L. DE C.V. (10082574)
- Roles
- Contract manufacturer, Repackager or relabeler
- First device listed
- August 17, 2021
- Registered through
- 2027
- Brand names listed
- : QuidelOrtho SOFIA 2 Campylobacter Fluorescent Immunoassay (FIA), CareStart COVID-19 Antigen Home Test, Immunoassay Test, Sofia® Strep A FIA, KARDIAMOBILE 6L_AliveCor, Inc, QUICKVUE+ Strep A Test, QuickVue At-Home OTC COVID-19 Test, QuickVue At-Home OTC COVID-19 Test 2 pack, QuickVue At-Home OTC COVID-19 Test 25pack and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antigens, All Groups, Streptococcus Spp. | GTY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Antisera, All Groups, Streptococcus Spp. | GTZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Assayed Quality Control Material For Clinical Microbiology Assays | QCH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Campylobacter Spp. | LQP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Coronavirus Antigen Detection Test System. | QKP | N | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Electrocardiograph Software For Over-The-Counter Use | QDA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Fluorometer, For Clinical Use | KHO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Reagent, Borrelia Serological Reagent | LSR | 2 | Repackager or relabeler | accessdata.fda.gov |
| Reagent, Occult Blood | KHE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 23, 2021 | K211342 | Sofia 2 Campylobacter FIA | LQP | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| May 10, 2019 | K183319 | Triangle System | DXH | Substantially Equivalent | AliveCor, Inc. | accessdata.fda.gov |
| August 30, 2018 | K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control Set | LSR | Substantially Equivalent | Quidel Corporation | accessdata.fda.gov |
| June 17, 2002 | K021423 | INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST | KHE | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| August 7, 1991 | K912868 | GROUP A STREP POSITIVE AND NEGATIVE CONTROLS | GTZ | Substantially Equivalent | Quidel Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Antigens, All Groups, Streptococcus Spp.
- All makers of Antisera, All Groups, Streptococcus Spp.
- All makers of Electrocardiograph
- All makers of Electrocardiograph Software For Over-The-Counter Use
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
- All makers of Coronavirus Antigen Detection Test System.
Updated November 23, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.