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Agglutination Method, Human Chorionic Gonadotropin

FDA product code JHJ · Class 2 · Clinical Chemistry

4
Registered devices
171
Adverse events
3
Recalls
96
510(k) clearances

Devices with this code

AutoDELFIA hCG kit — Wallac OyDetector Cept-D Polyclonal — Immunostics Company, IncAutoDELFIA hCG kit — Wallac OyDELFIA hCG kit — Wallac Oy

Recent recalls

DateFirmReason
2019-01-10PerkinElmer Life and Analytical Sciences, Wallac, OYhCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
2019-01-10PerkinElmer Life and Analytical Sciences, Wallac, OYhCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
2019-01-10PerkinElmer Life and Analytical Sciences, Wallac, OYhCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.