The products are used to monitor the chimeric status of stem cell or bone marrow transplant recipients.
The agency cleared the company's C-reactive protein, which is based on its Multi-Array technology used by life science researchers for 20 years.
Sebia and Janssen Biotech collaborated on the development of the test, which is for assessing patients treated with Darzalex.
The firm noted that the premarket approval means that the three major viral load assays that most laboratories run for patients are now available on a single system.
The test has been validated for use with the same full set of female urogenital specimens that are used with Cobas NT/NG testing, as well as for use with male urine.
The first available test on the PCR-based Accula platform will be for the diagnosis of influenza A and B virus infection.
The US Food and Drug Administration cleared Qiagen's Ipsogen JAK2 RGQ PCR Kit for additional use in the diagnosis of all myeloproliferative neoplasms
Executives at two commercial payors said they'd follow CMS' lead when it comes to patients covered under Medicare but beyond that their support for the agency's policy is less clear.
The tests detect Campylobacter jejuni and Campylobacter coli and improve upon currently available immunoassays and culture tests, the firm said.
Bio-Rad received 510(k) clearance for its IH-Incubator L and IH-Centrifuge L instruments for use with the company's full range of IH-System Gel Reagents.
The real-time PCR-based test is designed to identify EGFR mutations in circulating tumor DNA in plasma samples.
Diazyme's managing director said that the assay enables clinical labs "of almost any size" to run a vitamin D test in house without specialized instruments.
An extended labeling claim has added detection of three additional EGFR mutations to help ID NSCLC patients for whom Boehringer Ingelheim's Gilotrif is indicated.
The three firms each had 510(k) clearances for multiple products from the FDA last month for marketing.
The genetic testing firm can now offer its Prelude noninvasive prenatal test to residents in New York State.
The Ventana MMR IHC Panel is for detecting certain proteins associated with mismatch repair, and for differentiating between sporadic colorectal cancer and probable Lynch syndrome.
With WHO prequalification, global health organizations can consider the Aptima HIV-1 Quant Dx for public-sector procurement in resource-limited countries.
Myriad Genetics' BRACAnalysis CDx can identify which metastatic patients have BRCA mutations and would likely benefit from treatment with AstraZeneca's Lynparza.
The FDA said it observed a number of violations of federal law related to the company's Vacutainer blood collection tubes during an inspection.
At the JPM Healthcare Conference on Wednesday, its CEO also said that lower-than-anticipated revenues in Q4 2017 were due to a longer-than-expected sales cycle.