FDA Registration
Active
🇺🇸 United States
MOLECULAR TESTING LABS
Reg #: 3012598266
·
FEI: 3012598266
·
Expires 2026
Products
13
Proprietary Names
13
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- MOLECULAR TESTING LABS
- Registration Number
- 3012598266
- FEI Number
- 3012598266
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 14401 SE 1ST Street
- City
- Vancouver
- State
- WA
- ZIP
- 98684
- Country
- US
Regulatory Submissions
- 510(k) Number
- K132270
Owner / Operator
- Firm Name
- Molecular Testing Labs
- Operator Number
- 10081703
- Address
- 14401 SE 1ST Street
- City
- Vancouver
- State
- WA
- Postal Code
- 98684
- Country
- US
- Correspondent
- David DeLong
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2022-04-13 |
| Dna-Reagents, Neisseria | LSL | Class 2 | Microbiology | No | 2022-04-13 |
| Dna Probe, Nucleic Acid Amplification, Chlamydia | MKZ | Class 1 | Microbiology | No | 2022-04-13 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2022-04-13 |
| Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | QEP | Class 2 | Microbiology | No | 2023-12-20 |
| Trichomonas Vaginalis Nucleic Acid Amplification Test System | OUY | Class 2 | Immunology | No | 2023-12-20 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2023-12-20 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2021-05-07 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2022-04-13 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2022-04-13 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2022-04-13 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2021-05-07 |
| Automated Occult Blood Analyzer | OOX | Class 2 | Hematology | No | 2023-12-20 |
Proprietary Names
Adhesive bandage
Roche Cobas Urine PCR
Hologic Aptima Urine
Abbott Alinity m STI Assay
Urine Collection Cup no lid
Collection Kit - DNA Buccal Swab
Microtainer
Dried Blood Spot Card
Serum Separator Card
Gauze pad
Lancet
Collection Kit - Colorectal Cancer Screen
Fecal FIT PolyMed
Establishment Types
Repack or Relabel Medical Device