FDA Device Registration & Listing · TECATE Baja California, MX · Registration 3002792284
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| QKO | Reagent, Coronavirus Serological | Unknown | Class N | N/A | 2021-12-06 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | Microbiology | Class 2 | 866.3328 | 2014-04-17 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | Microbiology | Class 2 | 866.3328 | 2014-04-16 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | Microbiology | Class 1 | 866.3480 | 2014-04-17 |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | Microbiology | Class 1 | 866.3330 | 2023-01-19 |
| KXG | Applicator, Absorbent Tipped, Sterile | General Hospital | Class 1 | 880.6025 | 2023-01-19 |
| LQP | Campylobacter Spp. | Microbiology | Class 1 | 866.3110 | 2022-02-02 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | Microbiology | Class 1 | 866.3740 | 2014-04-17 |
| GTY | Antigens, All Groups, Streptococcus Spp. | Microbiology | Class 1 | 866.3740 | 2015-06-19 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | Class 2 | 862.1155 | 2008-01-25 |
| CKG | Radioimmunoassay, Acth | Clinical Chemistry | Class 2 | 862.1025 | 2014-05-21 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | Microbiology | Class 1 | 866.3480 | 2014-04-17 |
| GTY | Antigens, All Groups, Streptococcus Spp. | Microbiology | Class 1 | 866.3740 | 2014-04-16 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | Microbiology | Class 1 | 866.3740 | 2014-04-16 |
| LSR | Reagent, Borrelia Serological Reagent | Microbiology | Class 2 | 866.3830 | 2021-01-11 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | Microbiology | Class 1 | 866.3740 | 2014-04-17 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | Class 1 | 862.1660 | 2014-04-17 |
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | Microbiology | Class 2 | 866.3328 | 2022-01-03 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | Clinical Chemistry | Class 2 | 862.1155 | 2014-04-17 |
| CKG | Radioimmunoassay, Acth | Clinical Chemistry | Class 2 | 862.1025 | 2006-01-24 |
| LLH | Reagents, Clostridium Difficile Toxin | Microbiology | Class 1 | 866.2660 | 2021-12-10 |
| LYR | Helicobacter Pylori | Microbiology | Class 1 | 866.3110 | 2014-04-16 |
| 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 | 2014-04-16 |
| LSR | Reagent, Borrelia Serological Reagent | Microbiology | Class 2 | 866.3830 | 2021-01-11 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | Clinical Chemistry | Class 2 | 862.1155 | 2014-04-17 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | Clinical Chemistry | Class 2 | 862.1155 | 2014-04-16 |
| 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 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3026664926 | SCANTIBODIES LABORATORY INC. | San Diego, CA, US |
| 3033507883 | Laboratorios Scantibodies, S.A. de C.V. | Tijuana Baja California, MX |
| 2020808 | SCANTIBODIES LABORATORY, INC. | SANTEE, CA, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K133343 | Guangzhou Wondfo Biotech Co., Ltd. | WONDFO RAPID STREP A TEST | 2014-01-31 |
| K964108 | Direct Access Diagnostics | FACT PLUS PREGNANCY TEST | 1996-11-18 |
| K945514 | Princeton BioMeditech Corp. | LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG | 1995-02-10 |
| K150022 | Guangzhou Wondfo Biotech Co., Ltd. | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream | 2015-08-07 |
| K043443 | Guangzhou Wondfo Biotech Co., Ltd. | ONE STEP HCG URINE PREGNANCY TEST | 2005-04-08 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0042-2024 | Universal Meditech Inc. | 2 | One Step Pregnancy Test REF 100-01 |
| 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-0015-2014 | Sekisui Diagnostics LLC | 1 | Product Name: OSOM C. Difficile Toxin A/B Test
Catalog Numbers: 173 (for United States) and 173 E (for Europe).
The Test is a qualitative assay (in vitro diagnostic) that employs
immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears
The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3000308930 | Ortho-Clinical Diagnostics European Support Center | Illkirch, CEDEX Bas-Rhin, FR |
| 3007349751 | NANOENTEK INC | Hwaseong Gyeonggi, KR |
| 3013530901 | HANGZHOU ROLLMED CO.,LTD. | Hangzhou Zhejiang, CN |
| 3009585529 | ASSURE TECH. (HANGZHOU) CO., LTD. | Hangzhou Zhejiang, CN |
| 3016764932 | ZHEJIANG GENE SCIENCE CO., LTD | shaoxing Zhejiang, CN |
3002792284 when referencing this establishment in official correspondence.