FDA-Device2023-05-24Class II

Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates

IMMUNDIAGNOSTIK, Inc
Hazard

Marketed without a 510k

Sold states
US Nationwide Distribution: CA, IL, NC, NH, OR
Affected count
88 units
Manufactured in
400 Bedford St Ste 104, N/A, Manchester, NH, United States
Products
Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1603-2023

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