Diversified Synergies, LLC

FDA Device Registration & Listing · Detroit, MI, US · Registration 3023372670

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3023372670
FEI Number
3023372670
Entity Name
Diversified Synergies, LLC
City/State/Country
Detroit, MI, US
Establishment Address
201 Waterman St, Detroit, MI 48209, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Diversified Chemical Technologies (Owner Number: 10083482)
Owner / Operator Contact Address
15477 Woodrow Wilson, Detroit, MI 48238, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K232775
PMA Number
N/A

All Registered Proprietary Names

BinaxNOW COVID-19/Flu A&B Combo Self Test 2T BinaxNOW COVID-19/Flu A&B Combo Self Test 4T ID NOW Influenza A&B 2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
SCA Multi-Analyte Respiratory Virus Antigen Detection Test Microbiology Class 2 866.3987 2025-09-23
OCC Respiratory Virus Panel Nucleic Acid Assay System Microbiology Class 2 866.3980 2025-12-05
OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay Microbiology Class 2 866.3980 2025-12-05
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2025-12-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Diversified Chemical Technologies
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0042-2025 Luminex Molecular Diagnostics Inc 2
NxTAG Respiratory Pathogen Panel, REF: I051C0447

Similar Registrations

Registration Number Establishment Name Location
3005174594 NANO-DITECH CORPORATION Cranbury, NJ, US
1221359 Abbott Diagnostics Scarborough, Inc. Scarborough, ME, US
3008517993 ZHEJIANG ORIENT GENE BIOTECH Huzhou Zhejiang, CN
3016850770 BIOHIT HEALTHCARE (HEFEI) CO., LTD. Hefei Anhui, CN
3006048451 Confirm Biosciences LLC SAN DIEGO, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023372670. Last updated year: 2026. Please use registration number 3023372670 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.