Home › Device types › DDZ
Albumin, Fitc, Antigen, Antiserum, Control
FDA product code DDZ · Class 2 · Immunology
10
Registered devices
0
Adverse events
1
Recalls
4
510(k) clearances
Devices with this code
Anti Human Albumin FITC — KENT LABORATORIES INCMICROALBUMIN (mALB) — RANDOX LABORATORIES LIMITEDmALB — RANDOX LABORATORIES LIMITEDmALB — RANDOX LABORATORIES LIMITEDmALB — RANDOX LABORATORIES LIMITEDClearChem Diagnostics Inc. MicroAlbumin — CLEARCHEM DIAGNOSTICS INC.Pointe Scientific, Inc. Microalbumin — HORIBA INSTRUMENTS INCORPORATEDmALB — RANDOX LABORATORIES LIMITEDmALB — RANDOX LABORATORIES LIMITEDPoly Rb A-Hu Albumin/FITC — AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-31 | Randox Laboratories Ltd. | Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience |
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