FDA Registration
Active
🇲🇽 Mexico
LABORATORIOS SCANTIBODIES S.A. DE C.V.
Reg #: 3002792284
·
FEI: 3002792284
·
Expires 2026
Products
24
Proprietary Names
4
Establishment Types
3
Classifications
24
Registration Details
- Registration Name
- LABORATORIOS SCANTIBODIES S.A. DE C.V.
- Registration Number
- 3002792284
- FEI Number
- 3002792284
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Calle Los Vinedos #4100, Parque Industrial El Bajio CP 21430
- City
- TECATE Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K050748
Owner / Operator
- Firm Name
- Scantibodies Laboratory Inc.
- Operator Number
- 2020808
- Address
- 9336 Abraham Way, --
- City
- Santee
- State
- CA
- Postal Code
- 92071
- Country
- US
- Correspondent
- Angela Cancino
US Agent
- Business Name
- Angela Cancino
- Contact Name
- Angela Cancino
- Address
- 9336 Abraham Way
- City
- Santee
- State
- CA
- ZIP
- 92071
- Country
- US
- [email protected]
- Phone
- 619 7293951
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Reagent, Coronavirus Serological | QKO | Class N | Unknown | No | 2021-12-06 |
| Devices Detecting Influenza A, B, And C Virus Antigens | PSZ | Class 2 | Microbiology | No | 2014-04-17 |
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | GQG | Class 1 | Microbiology | No | 2014-04-17 |
| Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | GNX | Class 1 | Microbiology | No | 2023-01-19 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2023-01-19 |
| Campylobacter Spp. | LQP | Class 1 | Microbiology | No | 2022-02-02 |
| Antisera, All Groups, Streptococcus Spp. | GTZ | Class 1 | Microbiology | No | 2014-04-17 |
| Antigens, All Groups, Streptococcus Spp. | GTY | Class 1 | Microbiology | No | 2015-06-19 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2008-01-25 |
| Radioimmunoassay, Acth | CKG | Class 2 | Clinical Chemistry | No | 2014-05-21 |
| Reagent, Borrelia Serological Reagent | LSR | Class 2 | Microbiology | No | 2021-01-11 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2014-04-17 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2014-04-17 |
| Reagents, Clostridium Difficile Toxin | LLH | Class 1 | Microbiology | No | 2021-12-10 |
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2014-04-16 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2023-01-19 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2014-04-17 |
| Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | LJC | Class 1 | Microbiology | No | 2014-04-17 |
| System, Test, Infectious Mononucleosis | KTN | Class 2 | Immunology | No | 2014-04-17 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | QJR | Class N | Unknown | No | 2021-06-30 |
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2014-04-16 |
| Covid-19 Multi-Analyte Antigen Device | QMN | Class N | Unknown | No | 2020-11-20 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2020-11-18 |
| Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | QVF | Class 2 | Microbiology | No | 2023-07-13 |
Proprietary Names
QuickVue RSV
QuickVue+ Strep A
Sofia Strep A FIA
Sofia hCG FIA
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198