FDA.report

Microbiologics, Inc.

Matched from indexed company URL: MICROBIOLOGICS INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
10501381050138Microbiologics, Inc.1N2026-01-011040 Manchester St LEXINGTON KY US 40508
21501382150138MICROBIOLOGICS, INC.1Y2026-01-01200 Cooper Avenue North Saint Cloud MN US 56303

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
10845357044324Helix Elite™ Molecular Standards: Inactivated Standard - Helix Elite™ Molecular Standards Inactivated Negative Blank Control+1(320)253-7400techsupport@microbiologics.com
70845357044364QC Sets and Panels: Helix Elite™ - QC Sets and Panels: Helix Elite™ Rapid SARS-CoV-2 Control Panel+1(320)253-7400techsupport@microbiologics.com
70845357044388QC Sets and Panels: Helix Elite™ - QC Sets and Panels: Helix Elite™ Flu/RSV/SARS-CoV-2 Control Panel Sample Kit+1(320)253-7400techsupport@microbiologics.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
59731651044429K191172Cepheid Xpert MRSA NxG Control PanelPMN2019-06-20
59731355742154K191168Cepheid Xpert SA Nasal Complete Control PanelPMN2019-06-25
59731385317910K190463Cepheid Xpert C. difficile/Epi Control PanelPMN2019-04-19
59731661638692K190223Cepheid Xpert CT/NG Control PanelPMN2019-05-08
59732061186990K190086Cepheid Xpert Respiratory Control PanelPMN2019-10-07
59731948287641K182472Cepheid Xpert GBS LB Control PanelPMN2018-11-08
59731293143189K181711BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC PanelPMN2018-08-15
59731208029959K181683BD MAX CT/GC/TV 20-Day QC PanelPMN2018-08-28
59731134435831
59731191644687
3322701305005242
3322701718197930
59731729732055
59731773672461
3322701836691843
59731926900855
59732017050393

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
PMN82019-10-07

PMN

GUDID

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