Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013248161

FEI Number

3013248161

Entity Name

Labcorp Genetics

City/State/Country

San Francisco, CA, US

Establishment Address

1400 16th Street, San Francisco, CA 94103, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Labcorp Genetics (Owner Number: 10087208)

Owner / Operator Contact Address

1400 16th Street, San Francisco, CA 94103, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152464

PMA Number

N/A

All Registered Proprietary Names

Invitae RNA + Hereditary Cancer Blood Collection Kit Invitae Saliva Collection kit Invitae Straight Needle Phlebotomy Kit Invitae Butterfly Needle Phlebotomy Kit Invitae Blood PCM Collection Kit Invitae Blood Collection Kit Invitae Blood NDD Collection Kit Invitae Buccal Swab Specimen Collection Kit Invitae Buccal NDD Swab Specimen Collection Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	Class 2	862.1675	2023-02-07
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2023-02-13
OFM	Phlebotomy Blood Collection Kit	Cardiovascular	Class 2	870.2750	2024-06-20
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2023-08-17
OYJ	Dna Specimen Collection, Saliva	Clinical Chemistry	Class 2	862.1675	2023-02-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Labcorp Genetics

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
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

Similar Registrations

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3026940910	SPOT HEALTH INC.	Cincinnati, OH, US
3020139194	LetsGetChecked Inc.	Cucamonga, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013248161. Last updated year: 2026. Please use registration number 3013248161 when referencing this establishment in official correspondence.