FDA Device Registration & Listing · Tijuana Baja California, MX · Registration 3033507883
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | Class 1 | 862.1660 | 2014-04-17 |
| QKO | Reagent, Coronavirus Serological | Unknown | Class N | N/A | 2021-12-06 |
| KHO | Fluorometer, For Clinical Use | Clinical Chemistry | Class 1 | 862.2560 | 2014-04-17 |
| GTY | Antigens, All Groups, Streptococcus Spp. | Microbiology | Class 1 | 866.3740 | 2014-04-17 |
| NNI | Container, Specimen, Non-Sterile | Pathology | Class 1 | 864.3250 | 2023-01-19 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | Clinical Chemistry | Class 2 | 862.1155 | 2014-04-17 |
| KTN | System, Test, Infectious Mononucleosis | Immunology | Class 2 | 866.5640 | 2014-04-17 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | Class 1 | 862.1660 | 2014-04-17 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | Microbiology | Class 1 | 866.3740 | 2014-04-16 |
| KHE | Reagent, Occult Blood | Hematology | Class 2 | 864.6550 | 2014-04-16 |
| QMN | Covid-19 Multi-Analyte Antigen Device | Unknown | Class N | N/A | 2020-11-20 |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | Microbiology | Class 1 | 866.3330 | 2023-01-19 |
| GTY | Antigens, All Groups, Streptococcus Spp. | Microbiology | Class 1 | 866.3740 | 2014-04-17 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | Microbiology | Class 2 | 866.3328 | 2014-04-17 |
| LSR | Reagent, Borrelia Serological Reagent | Microbiology | Class 2 | 866.3830 | 2021-01-11 |
| GTY | Antigens, All Groups, Streptococcus Spp. | Microbiology | Class 1 | 866.3740 | 2015-06-19 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | Clinical Chemistry | Class 2 | 862.1155 | 2014-04-16 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | Microbiology | Class 1 | 866.3740 | 2014-04-17 |
| LYR | Helicobacter Pylori | Microbiology | Class 1 | 866.3110 | 2014-04-16 |
| KXG | Applicator, Absorbent Tipped, Sterile | General Hospital | Class 1 | 880.6025 | 2023-01-19 |
| QKP | Coronavirus Antigen Detection Test System. | Unknown | Class N | N/A | 2020-11-18 |
| LQP | Campylobacter Spp. | Microbiology | Class 1 | 866.3110 | 2022-02-02 |
| GTY | Antigens, All Groups, Streptococcus Spp. | Microbiology | Class 1 | 866.3740 | 2014-04-16 |
| KHO | Fluorometer, For Clinical Use | Clinical Chemistry | Class 1 | 862.2560 | 2014-04-17 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | Microbiology | Class 2 | 866.3328 | 2014-04-17 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | Microbiology | Class 1 | 866.3480 | 2014-04-17 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | Microbiology | Class 1 | 866.3740 | 2014-04-17 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | Class 2 | 862.1155 | 2008-01-25 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | Microbiology | Class 2 | 866.3328 | 2022-01-03 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | Microbiology | Class 1 | 866.3480 | 2014-04-17 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3026664926 | SCANTIBODIES LABORATORY INC. | San Diego, CA, US |
| 3002792284 | LABORATORIOS SCANTIBODIES S.A. DE C.V. | TECATE Baja California, MX |
| 2020808 | SCANTIBODIES LABORATORY, INC. | SANTEE, CA, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K103744 | Quantimetrix Corp. | DROPPER A1C DIABETES CONTROL | 2011-05-12 |
| K981281 | Roche Diagnostics GmbH | ELECSYS CALCHECK FERRITIN | 1998-04-24 |
| K981278 | Roche Diagnostics GmbH | ELECSYS CALCHECK CA 125II | 1998-04-23 |
| K143687 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material | 2015-07-17 |
| K143376 | Siemens Healthcare Diagnostics, Inc. | ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material | 2014-12-23 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0007-2008 | Tosoh Bioscience Inc | 1 | 4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic. |
| Z-0006-05 | Abbott Health Products, Inc. | 2 | AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21 |
| Z-0001-2023 | Jiangsu Well Biotech Co., Ltd. No | N | Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02 |
| Z-0042-2024 | Universal Meditech Inc. | 2 | One Step Pregnancy Test REF 100-01 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3007652384 | MICROBIX | Mississauga Ontario, CA |
| 3014353121 | VIDAN DIAGNOSTICS, LLC | San Antonio, TX, US |
| 3008514395 | Telcare, LLC | Linwood, PA, US |
| 3012118659 | ASCENSIA DIABETES CARE HOLDINGS AG | Basel Basel-Stadt, CH |
| 1319681 | ORTHO-CLINICAL DIAGNOSTICS, INC. | Rochester, NY, US |
3033507883 when referencing this establishment in official correspondence.