Is this your brand? Sign in to claim ownership.

MESA BIOTECH, INC.

Last updated May 30, 2026

Information

Device	Model / Reference	Registries	Class	Status
Accula SARS CoV-2 Control Kit	COV4100-1	FDA UDI	N/A	Active
Silaris RSV Supplemental Pack	1040	FDA UDI	Class II	Active
Accula Programming Cassette	D2001	FDA UDI	N	Active
Silaris Influenza A&B Test	1027	FDA UDI	Class II	Active
SilarisTM Influenza A&B Starter Pack	1028	FDA UDI	Class II	Active
Silaris RSV Test	1030	FDA UDI	N/A	Active
Silaris Influenza A&B Control Kit	1024	FDA UDI	Class II	Active
Silaris Dock	1026	FDA UDI	Class II	Active
Accula Flu A / B Control Kit	FAB1100CW-C	FDA UDI	Class II	Active
Sialris Influenza A&B Supplemental Pack	1035	FDA UDI	Class II	Active
Accula Dock	D2000	FDA UDI	N	Active
Accula Flu A / B Test	FAB1100CW	FDA UDI	Class II	Active
Silaris RSV Control Kit	1029	FDA UDI	Class II	Active
Accula SARS-CoV-2 Test	COV4100	FDA UDI	N	Active
Accula Strep A Test	K201269	FDA 510(k)	Class II	Active
Accula Flu A/Flu B Test	K171641	FDA 510(k)	Class II	Active
Accula RSV Test	K181443	FDA 510(k)	Class II	Active

No authorised representatives on record.

Not available yet.

Not available yet.

Not available yet.

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 6, 2022	Z-1009-2022	—	open, classified	SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.