Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006546675

FEI Number

3006546675

Entity Name

GRYPHUS DIAGNOSTICS, L.L.C.

City/State/Country

KNOXVILLE, TN, US

Establishment Address

900 E Hill Ave Ste 400, KNOXVILLE, TN 37915, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GRYPHUS DIAGNOSTICS, L.L.C. (Owner Number: 9035768)

Owner / Operator Contact Address

900 E Hill Ave Ste 400, Knoxville, TN 37915, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

POCKIT BV QUADRO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MXB	Test, Vaginal, Bacterial Sialidase	Microbiology	Class 1	866.2660	2000-05-26

Official Correspondent

STEPHEN JOHNSON, PH.D.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GRYPHUS DIAGNOSTICS, L.L.C.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006546675. Last updated year: 2026. Please use registration number 3006546675 when referencing this establishment in official correspondence.