510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Nuclein, LLC

Austin, TX, US

Nuclein, LLC appears in FDA device records in Austin, TX. FDA records list one 510(k) clearance, no PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
2
Registered establishments
2

510(k) clearance history

FDA records hold 1 510(k) clearance for Nuclein, LLC in 2024.

Clearances by year, as a table
510(k) clearance decisions for Nuclein, LLC, by decision year
YearClearances
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K241652DASH® SARS-CoV-2 & Flu A/B TestQOFSubstantially Equivalent

Registered establishments

FDA registered establishments for Nuclein, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30145157023014515702Nuclein, LLC8305 Cross Park Dr, Austin, TX 78754 US2026
30353816413035381641Nuclein, LLC500 Center Ridge Dr Ste 400, Austin, TX 78753 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2861-2026Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases. Component: No.Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).Class IIOpen, Classified
Z-2274-2025DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain