Home › Device types › JCM
Control, Hemoglobin, Abnormal
FDA product code JCM · Class 2 · Hematology
19
Registered devices
2
Adverse events
1
Recalls
12
510(k) clearances
Devices with this code
Lyphochek — BIO-RAD LABORATORIES, INC.Abnormal HbA2 Quik Column Control — HELENA LABORATORIES CORPORATIONExtendSURE — CANTERBURY SCIENTIFIC LIMITEDHb AFSA2 CONTROL (5) — SEBIATrinity Biotech — PRIMUS CORPORATIONTrinity Biotech — PRIMUS CORPORATIONAdvin Multi-Drug Screen Test — ADVIN BIOTECH, INC.Hb AFSA2 CONTROL (1) — SEBIAExtendSURE — CANTERBURY SCIENTIFIC LIMITEDHb AFSC Control — SEBIAExtendSURE — CANTERBURY SCIENTIFIC LIMITEDCAPI 3 NEONAT Hb AF Control — SEBIARESOLVE Hb FACS Control kit — Wallac OyNormal HbA2 Quik Column Control — HELENA LABORATORIES CORPORATIONTrinity Biotech — PRIMUS CORPORATIONTrinity Biotech — PRIMUS CORPORATIONTosoh US — CANTERBURY SCIENTIFIC LIMITEDTosoh EU — CANTERBURY SCIENTIFIC LIMITEDLyphochek — BIO-RAD LABORATORIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-11-07 | Tosoh Bioscience, Inc. | The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negati |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.