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Enzyme Controls (Assayed And Unassayed)
FDA product code JJT · Class 1 · Clinical Chemistry
24
Registered devices
18
Adverse events
2
Recalls
97
510(k) clearances
Devices with this code
Enzymer ER Verifier, Level G — VERICHEM LABORATORIES, INC.ARCHITECT — ABBOTT LABORATORIESEnzymer ER Verifier Kit — VERICHEM LABORATORIES, INC.CK/LD Isoenzyme Control (5 x 2 mL) — HELENA LABORATORIES CORPORATIONCardiac Control Marker — MORE DIAGNOSTICS INCCholestech LDX™ — Alere San Diego, Inc.SPOTCHECK — ASTORIA-PACIFIC, INC.Cardiac Marker Control — MORE DIAGNOSTICS INCCardiac Marker Control — MORE DIAGNOSTICS INCCalCheck ISD — Roche Diagnostics GmbHARCHITECT — ABBOTT LABORATORIESLiquichek — BIO-RAD LABORATORIES, INC.Enzymer Verifier Kit — VERICHEM LABORATORIES, INC.Prodigy AutoCode Blood Glucose Monitoring System — Prodigy Diabetes Care, LLCARCHITECT — ABBOTT LABORATORIESAlere Cholestech LDX® — Alere San Diego, Inc.SPOTCHECK — ASTORIA-PACIFIC, INC.Liquichek — BIO-RAD LABORATORIES, INC.Liquichek — BIO-RAD LABORATORIES, INC.SPOTCHECK — ASTORIA-PACIFIC, INC.ARCHITECT — ABBOTT LABORATORIESCardiac Marker Control — MORE DIAGNOSTICS INCSPOTCHECK — ASTORIA-PACIFIC, INC.PreciControl ISD — Roche Diagnostics GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-07-19 | Abbott Point Of Care Inc. | Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039); i-STAT |
| 2003-01-08 | PerkinElmer LIfe Sciences Inc | The Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed. |
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