Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012598266

FEI Number

3012598266

Entity Name

MOLECULAR TESTING LABS

City/State/Country

Vancouver, WA, US

Establishment Address

14401 SE 1ST Street, Vancouver, WA 98684, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Molecular Testing Labs (Owner Number: 10081703)

Owner / Operator Contact Address

14401 SE 1ST Street, Vancouver, WA 98684, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Adhesive bandage Roche Cobas Urine PCR Hologic Aptima Urine Abbott Alinity m STI Assay Urine Collection Cup no lid

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-04-13
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2022-04-13
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2022-04-13
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2022-04-13
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2022-04-13
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2022-04-13
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia	Microbiology	Class 1	866.3120	2023-12-20
LSL	Dna-Reagents, Neisseria	Microbiology	Class 2	866.3390	2023-12-20
QEP	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	Microbiology	Class 2	866.3393	2023-12-20
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System	Immunology	Class 2	866.3860	2023-12-20
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2023-12-20
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2023-12-20

Official Correspondent

David DeLong

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Molecular Testing Labs

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Similar Registrations

Registration Number	Establishment Name	Location
3009662219	Custom Medical and Safety Products Inc.	Buffalo, NY, US
3014553350	CORRECT BREATHING CONCEPTS, LLC	Painesville, OH, US
3023122974	MBET HEALTH, LLC	Tarzana, CA, US
3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
3019843433	The Natural Patch Company Pty Ltd	Prahran Victoria, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012598266. Last updated year: 2026. Please use registration number 3012598266 when referencing this establishment in official correspondence.