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Microbiology devices: recent FDA 510(k) clearances

21 microbiology devices: recent FDA 510(k) clearances are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23; the most frequent is Roche Diagnostics with 3. Data last updated 2026-11-03; each record links to its official source and a full report.

Data as of · Compiled by Zalwin from U.S. FDA openFDA

Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe

Free sample: 3 records (CSV)

21 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23. Most frequent: Roche Diagnostics (3). Each record links to a full report and the official source.

Last updated 2026-11-03. Source: U.S. FDA openFDA.

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Records
21
Most frequent
  1. Roche Diagnostics (3)
  2. Cepheid® (2)
  3. Centers for Disease Control and Prevention (2)
  4. B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) (1)
  5. bioMerieux, Inc. (1)

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What are the top microbiology devices: recent FDA 510(k) clearances right now?

RecordSpecialtyTypeDate
B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC (K260302): 510(k) cleared for B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific)Microbiology510(k)2026-10-23
Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche DiagnosticsMicrobiology510(k)2026-10-02
Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche DiagnosticsMicrobiology510(k)2026-10-02
Elecsys EBV IgM (K260233): 510(k) cleared for Roche DiagnosticsMicrobiology510(k)2026-10-02
VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) (K260283): 510(k) cleared for bioMerieux, Inc.Microbiology510(k)2026-10-01
DASH Flu A/B Test (K261347): 510(k) cleared for Nuclein, LLCMicrobiology510(k)2026-10-21
Access MeMed BV (K261109): 510(k) cleared for Beckman Coulter, Inc.Microbiology510(k)2026-10-19
VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc.Microbiology510(k)2026-09-28
Xpert Respiratory Panel (K261336): 510(k) cleared for CepheidMicrobiology510(k)2026-09-25
Xpert Xpress CoV-2/Flu plus (K263333): 510(k) cleared for Cepheid®Microbiology510(k)2026-10-22
BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics, LLCMicrobiology510(k)2026-10-21
SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (K262573): 510(k) cleared for Maine Molecular Quality Controls, Inc.Microbiology510(k)2026-10-21
Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid®Microbiology510(k)2026-10-02
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit) (K263035): 510(k) cleared for Centers for Disease Control and PreventionMicrobiology510(k)2026-09-30
BIOFIRE Respiratory Panel 2.1 (RP2.1) (K263054): 510(k) cleared for Biofire DiagnosticsMicrobiology510(k)2026-09-22
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test (K262432): 510(k) cleared for CorDx, Inc. 🔒 Unlock all 21 records →
B. anthracis Real-time PCR Assay (K262368): 510(k) cleared for Centers for Disease Control and Prevention 🔒 Unlock all 21 records →
QIAstat-Dx BCID GN Plus AMR Panel (K262168): 510(k) cleared for QIAGEN GmbH 🔒 Unlock all 21 records →
Browse 6 more matching record reports

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Which related categories and locations should I check?

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510(k) clearances (414) Class II device recalls (320) Class I device recalls (19) Class III device recalls (11)

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Radiology (56) Orthopedic (53) Cardiovascular (52) General & Plastic Surgery (44) Dental (32) Gastroenterology & Urology (27) Neurology (23) Microbiology (21) Clinical Chemistry (15) General Hospital (14) Anesthesiology (12) Obstetrics & Gynecology (9) Ophthalmic (7)

Browse by record type by specialty

Radiology devices: recent FDA 510(k) clearances (56) Orthopedic devices: recent FDA 510(k) clearances (53) Cardiovascular devices: recent FDA 510(k) clearances (52) General & Plastic Surgery devices: recent FDA 510(k) clearances (44) Dental devices: recent FDA 510(k) clearances (32) Gastroenterology & Urology devices: recent FDA 510(k) clearances (27) Neurology devices: recent FDA 510(k) clearances (23) Clinical Chemistry devices: recent FDA 510(k) clearances (15) General Hospital devices: recent FDA 510(k) clearances (14) Anesthesiology devices: recent FDA 510(k) clearances (12) Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9) Ophthalmic devices: recent FDA 510(k) clearances (7)

Frequently asked questions

How many microbiology devices: recent FDA 510(k) clearances are listed?

21 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-23.

Can I get alerts for Microbiology devices: recent FDA 510(k) clearances?

Yes. FDAPulse can email you new records matching this filter; plans are listed on the FDAPulse page.

Source: U.S. FDA openFDA. Informational only. RSS feed of new records

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