- [Home](/) › - [FDAPulse](/v/fdapulse) › - [Hubs](/hub/fdapulse) › - Microbiology # FDA 510(k) clearances and recalls: Microbiology devices **21 FDA 510(k) clearances and recalls: Microbiology devices 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 2026-11-04; each record links to its official source and a full report.** Data as of 2026-11-04 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA Copy citation Download all 21 FDA 510(k) clearances and recalls: Microbiology devices (CSV) — $4.99 → 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)](/v1/verticals/fdapulse/records.csv?panel=Microbiology) 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 2026-11-04. Source: U.S. FDA openFDA. **Search, filter and export FDAPulse records** [Run instant live search with these filters](/v/fdapulse?panel=Microbiology&channel=pseo#vt-out) [Download free 3-row sample CSV](/v1/verticals/fdapulse/records.csv?panel=Microbiology) Unlock the full CSV for these filters — $4.99 → ✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days ## Get new FDAPulse records by email (free, weekly) We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email. Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe. [See this week's digest](/digest/fdapulse) Records 21 Most frequent - Roche Diagnostics (3) - Cepheid® (2) - Centers for Disease Control and Prevention (2) - B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific) (1) - bioMerieux, Inc. (1) ## How do I get new FDA 510(k) clearances and recalls: Microbiology devices by email? Search, filter and export these records, or get alerts when new ones appear. [Search and filter](/v/fdapulse?panel=Microbiology) [Watch this exact filter](/v/fdapulse?panel=Microbiology#more-ways) [See alert plans](/v/fdapulse#pricing) ## What are the top FDA 510(k) clearances and recalls: Microbiology devices right now? | Record | Specialty | Type | Date | |---|---|---|---| | 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) | Microbiology | 510(k) | 2026-10-23 | | Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics | Microbiology | 510(k) | 2026-10-02 | | Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics | Microbiology | 510(k) | 2026-10-02 | | Elecsys EBV IgM (K260233): 510(k) cleared for Roche Diagnostics | Microbiology | 510(k) | 2026-10-02 | | VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) (K260283): 510(k) cleared for bioMerieux, Inc. | Microbiology | 510(k) | 2026-10-01 | | DASH Flu A/B Test (K261347): 510(k) cleared for Nuclein, LLC | Microbiology | 510(k) | 2026-10-21 | | Access MeMed BV (K261109): 510(k) cleared for Beckman Coulter, Inc. | Microbiology | 510(k) | 2026-10-19 | | VITEK 2 AST-Streptococcus Cefepime (=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc. | Microbiology | 510(k) | 2026-09-28 | | Xpert Respiratory Panel (K261336): 510(k) cleared for Cepheid | Microbiology | 510(k) | 2026-09-25 | | Xpert Xpress CoV-2/Flu plus (K263333): 510(k) cleared for Cepheid® | Microbiology | 510(k) | 2026-10-22 | | BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics, LLC | Microbiology | 510(k) | 2026-10-21 | | SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (K262573): 510(k) cleared for Maine Molecular Quality Controls, Inc. | Microbiology | 510(k) | 2026-10-21 | | Xpert Xpress CoV-2/Flu plus (K263120): 510(k) cleared for Cepheid® | Microbiology | 510(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 Prevention | Microbiology | 510(k) | 2026-09-30 | | BIOFIRE Respiratory Panel 2.1 (RP2.1) (K263054): 510(k) cleared for Biofire Diagnostics | Microbiology | 510(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. | Included in the full CSV with every column 🔒 Unlock all 21 records → | | B. anthracis Real-time PCR Assay (K262368): 510(k) cleared for Centers for Disease Control and Prevention | Included in the full CSV with every column 🔒 Unlock all 21 records → | | QIAstat-Dx BCID GN Plus AMR Panel (K262168): 510(k) cleared for QIAGEN GmbH | Included in the full CSV with every column 🔒 Unlock all 21 records → | Browse 6 more matching record reports - [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.](/report/fdapulse/cordx-tyfast-flu-a-b-and-covid-19-at-home-multiplex-rapid-ga--k262432) - [B. anthracis Real-time PCR Assay (K262368): 510(k) cleared for Centers for Disease Control and Prevention](/report/fdapulse/b-anthracis-real-time-pcr-assay-k262368-ga--k262368) - [QIAstat-Dx BCID GN Plus AMR Panel (K262168): 510(k) cleared for QIAGEN GmbH](/report/fdapulse/qiastat-dx-bcid-gn-plus-amr-panel-k262168-de--k262168) - [Anti-HCV Next (K262156): 510(k) cleared for Abbott Laboratories](/report/fdapulse/anti-hcv-next-k262156-il--k262156) - [BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth (K262163): 510(k) cleared for Becton Dickinson and Company](/report/fdapulse/bd-bbl-mueller-hinton-ii-broth-cation-adjusted-bd-difco-md--k262163) - [FINDER Flu A&B/SARS-CoV-2 Test (K261837): 510(k) cleared for Baebies, Inc.](/report/fdapulse/finder-flu-a-and-b-sars-cov-2-test-k261837-nc--k261837) [Browse all FDAPulse record reports](/hub/fdapulse/records) ## Which related categories and locations should I check? ### Browse by record type [510(k) clearances (414)](/hub/fdapulse/type/510k-clearances) [Class II device recalls (320)](/hub/fdapulse/type/class-ii-recalls) [Class I device recalls (19)](/hub/fdapulse/type/class-i-recalls) [Class III device recalls (11)](/hub/fdapulse/type/class-iii-recalls) ### Browse by specialty [Radiology (56)](/hub/fdapulse/specialty/radiology) [Orthopedic (53)](/hub/fdapulse/specialty/orthopedic) [Cardiovascular (52)](/hub/fdapulse/specialty/cardiovascular) [General & Plastic Surgery (44)](/hub/fdapulse/specialty/general-plastic-surgery) [Dental (32)](/hub/fdapulse/specialty/dental) [Gastroenterology & Urology (27)](/hub/fdapulse/specialty/gastroenterology-urology) [Neurology (23)](/hub/fdapulse/specialty/neurology) [Clinical Chemistry (15)](/hub/fdapulse/specialty/clinical-chemistry) [General Hospital (14)](/hub/fdapulse/specialty/general-hospital) [Anesthesiology (12)](/hub/fdapulse/specialty/anesthesiology) [Obstetrics & Gynecology (9)](/hub/fdapulse/specialty/obstetrics-gynecology) [Ophthalmic (7)](/hub/fdapulse/specialty/ophthalmic) ### Browse by record type by specialty [Radiology devices: recent FDA 510(k) clearances (56)](/hub/fdapulse/specialty_type/radiology--510k-clearances) [Orthopedic devices: recent FDA 510(k) clearances (53)](/hub/fdapulse/specialty_type/orthopedic--510k-clearances) [Cardiovascular devices: recent FDA 510(k) clearances (52)](/hub/fdapulse/specialty_type/cardiovascular--510k-clearances) [General & Plastic Surgery devices: recent FDA 510(k) clearances (44)](/hub/fdapulse/specialty_type/general-plastic-surgery--510k-clearances) [Dental devices: recent FDA 510(k) clearances (32)](/hub/fdapulse/specialty_type/dental--510k-clearances) [Gastroenterology & Urology devices: recent FDA 510(k) clearances (27)](/hub/fdapulse/specialty_type/gastroenterology-urology--510k-clearances) [Neurology devices: recent FDA 510(k) clearances (23)](/hub/fdapulse/specialty_type/neurology--510k-clearances) [Microbiology devices: recent FDA 510(k) clearances (21)](/hub/fdapulse/specialty_type/microbiology--510k-clearances) [Clinical Chemistry devices: recent FDA 510(k) clearances (15)](/hub/fdapulse/specialty_type/clinical-chemistry--510k-clearances) [General Hospital devices: recent FDA 510(k) clearances (14)](/hub/fdapulse/specialty_type/general-hospital--510k-clearances) [Anesthesiology devices: recent FDA 510(k) clearances (12)](/hub/fdapulse/specialty_type/anesthesiology--510k-clearances) [Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9)](/hub/fdapulse/specialty_type/obstetrics-gynecology--510k-clearances) [Ophthalmic devices: recent FDA 510(k) clearances (7)](/hub/fdapulse/specialty_type/ophthalmic--510k-clearances) ## Frequently asked questions ### How many FDA 510(k) clearances and recalls: Microbiology devices 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? 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](/feed/fdapulse.xml) ## Often used together - [NPIPulse](/v/npipulse) - [EPAPulse](/v/epapulse) - [Municipal Public Works Prime Contract Operating Permit Renewal Pulse](/v/pubworksregrenewpulse) - [TrialRecruitmentPageAudit](/trialrecruitmentpageaudit) - [SubdomainShadowPulse](/subdomainshadowpulse) - [MigrationSignalRadar](/migrationsignalradar) Or get the [Healthcare Vendor Bundle](/v/fdapulse#more-ways) for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.