Medmira Laboratories Inc

FDA Filings

This page includes the latest FDA filings for Medmira Laboratories Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003595936
• FEI Number: 3003595936
• Name: Yolanda Smith
• Owner & Operator: MEDMIRA LABORATORIES, INC.
• Contact Address: 155 CHAIN LAKE DR. SUITE 1; HALIFAX CA-NS Nova Scotia B3S 1B3 CA
• Official Correspondent:
  • Hermes Chan
  • 1-902-4501588-x
• US Agent:
  • Yolanda Smith
  • Smith Associates
  • 410 4510639
  • 410 7930448
  • ysmith9746@aol.com
• Importing Logistics Registration:
  • Importer: Montgomery (NEDC), NY DC
  • Address: 500 Neelytown Road ; Montgomery, NY 12549 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1468 Harwell Avenue ; Crofton, MD 21114 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 10628451188268 MedMira Laboratories Inc	HIV-1/2 Antibody Test Controls	2024-04-19
GUDID 10628451188251 MedMira Laboratories Inc	HIV-1/2 Antibody Test Controls	2024-04-19
GUDID 10628451188244 MedMira Laboratories Inc	Reveal G4 Rapid HIV-1/2 Antibody Test	2024-04-19
GUDID 10628451188237 MedMira Laboratories Inc	Reveal G4 Rapid HIV-1/2 Antibody Test	2024-04-19
GUDID 10628451188220 MedMira Laboratories Inc	Reveal G4 Rapid HIV-1/2 Antibody Test	2024-04-19
GUDID 10628451188213 MedMira Laboratories Inc	HIV-1/2 Antibody Test Controls	2024-04-19
GUDID 00628451188209 MedMira Laboratories Inc	HIV-1/2 Antibody Test Controls	2024-04-19
GUDID 00628451188193 MedMira Laboratories Inc	Reveal G4 Rapid HIV-1/2 Antibody Test	2024-04-19
GUDID 00628451188186 MedMira Laboratories Inc	Reveal G4 Rapid HIV-1/2 Antibody Test	2024-04-19
GUDID 00628451188179 MedMira Laboratories Inc	Reveal G4 Rapid HIV-1/2 Antibody Test	2024-04-18
GUDID 10628451188169 MedMira Laboratories Inc	Reveal G4 Rapid HIV-1/2 Antibody Test	2024-04-16
GUDID 10628451188152 MedMira Laboratories Inc	HIV-1 Antibody Test Controls	2022-06-10
GUDID 10628451188145 MedMira Laboratories Inc	HIV-1 Antibody Test Controls	2022-06-10
GUDID 10628451188138 MedMira Laboratories Inc	Reveal G4 Rapid HIV-1 Antibody Test	2022-06-10
GUDID 10628451188121 MedMira Laboratories Inc	Reveal G4 Rapid HIV-1 Antibody Test	2022-06-10
GUDID 10628451188114 MedMira Laboratories Inc	Reveal G4 Rapid HIV-1 Antibody Test	2022-06-10
GUDID 10628451188107 MedMira Laboratories Inc	HIV-1 Antibody Test Controls	2022-06-10
GUDID 10628451188022 MedMira Laboratories Inc	Reveal G3 Rapid HIV-1 Antibody Test 815311007569	2022-06-10
GUDID 00628451188094 MedMira Laboratories Inc	Universal Buffer	2018-07-06
GUDID 00628451188087 MedMira Laboratories Inc	HIV-1 Antibody Test Controls	2018-07-06
GUDID 00628451188070 MedMira Laboratories Inc	Reveal G4 Rapid HIV-1 Antibody Test	2018-07-06
GUDID 00628451188063 MedMira Laboratories Inc	Reveal G4 Rapid HIV-1 Antibody Test	2018-07-06
GUDID 00628451188056 MedMira Laboratories Inc	Reveal G4 Rapid HIV-1 Antibody Test	2018-07-06
GUDID 00628451188049 MedMira Laboratories Inc	MedMira Universal Buffer 1009785RDB-G3	2018-07-06
GUDID 00628451188032 MedMira Laboratories Inc	MedMira Human HIV-1 Human Test Control 1009785RCP-G3	2018-07-06
GUDID 00628451188018 MedMira Laboratories Inc	Reveal G3 Rapid HIV-1 Antibody Test 815311000591	2018-07-06
PMN BP000023 | MZF Yolanda Smith [MEDMIRA LABORATORIES, INC.]	Reveal G4 Rapid HIV-1 Antibody Test	2007-12-05
PMN K002023 | LYR Yolanda Smith [MEDMIRA LABORATORIES, INC.]	MedMira H. pylori Test	2003-03-21
PMN K002023 MEDMIRA LABORATORIES, INC.	MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714	2000-11-13