Home › Device types › JBD
System, Analysis, Electrophoretic Hemoglobin
FDA product code JBD · Class 2 · Hematology
21
Registered devices
2
Adverse events
3
Recalls
26
510(k) clearances
Devices with this code
QuickGel Applicator Blade and Shallow Well Cups — HELENA LABORATORIES CORPORATIONSPIFE 4000 Alkaline Hemoglobin Gel Kit — HELENA LABORATORIES CORPORATIONAFSA2 Hemo Control — HELENA LABORATORIES CORPORATIONSPIFE Acid Hemoglobin Kit — HELENA LABORATORIES CORPORATIONAA2 Hemo Control — HELENA LABORATORIES CORPORATIONSupre-Heme Buffer — HELENA LABORATORIES CORPORATIONAFSC Hemo Control — HELENA LABORATORIES CORPORATIONSPIFE 4000 Acid Hemoglobin Kit — HELENA LABORATORIES CORPORATIONSPIFE Acid Hemoglobin Kit — HELENA LABORATORIES CORPORATIONQuickGel Acid Hemoglobin 10/20 Gel Kit — HELENA LABORATORIES CORPORATIONTitan IV Citrate Agar Plate — HELENA LABORATORIES CORPORATIONSPIFE Hemoglobin IEF Kit — HELENA LABORATORIES CORPORATIONTitan III-H Cellulose Acetate Plate — HELENA LABORATORIES CORPORATIONQuickGel Accessory Kit — HELENA LABORATORIES CORPORATIONSPIFE Nexus Acid Hemoglobin Kit — HELENA LABORATORIES CORPORATIONElectra HR Buffer — HELENA LABORATORIES CORPORATIONQuickGel Alkaline Hemoglobin Gel Kit — HELENA LABORATORIES CORPORATIONASA2 Hemo Control — HELENA LABORATORIES CORPORATIONSPIFE Nexus Alkaline Hemoglobin Gel Kit — HELENA LABORATORIES CORPORATIONTitan III-H Cellulose Acetate Plate — HELENA LABORATORIES CORPORATIONSPIFE Alkaline Hemoglobin Gel Kit — HELENA LABORATORIES CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-02-27 | Helena Laboratories, Corp. | Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated |
| 2006-08-29 | Sebia, Inc. | The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction. |
| 2004-06-29 | PerkinElmer LAS Inc | Hemoglobin Test Kit Catholyte Solution generating false positive results, were distributed. |
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