Sterling Diagnostics, Inc.
Sterling Diagnostics, Inc. holds FDA 510(k) medical device clearances, first cleared 1985, most recent 1993, with 9 FDA device recalls on record.
Top product codes for Sterling Diagnostics, Inc.
FDA recalls by Sterling Diagnostics, Inc.
- Z-0936-2017 — Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
- Z-0934-2017 — Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
- Z-0932-2017 — Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
- Z-0931-2017 — Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
- Z-0935-2017 — Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
- Z-0937-2017 — Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
- Z-0929-2017 — Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
- Z-0930-2017 — Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
- Z-0933-2017 — Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Sterling Diagnostics, Inc.
- K921412 — MICROPROTEIN REAGENT SET
- K914609 — TRIGLYCERIDES REAGENT SET
- K914039 — SODIUM REAGENT SET
- K914040 — PHOSPHOLIPID REAGENT SET
- K862255 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)
- K861962 — VANILMANDELIC ACID (VMA) REAGENT SET
- K862210 — UREA NITROGEN (GLDH) REAGENT SET (UV)
- K862256 — ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET
- K862209 — ALT (SGPT) REAGENT SET (UV RATE)
- K861855 — HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET
- K861615 — SALICYLATE REAGENT SET
- K861713 — SERUM POTASSIUM REAGENT SET
- K860350 — SERUM CHOLINESTERASE REAGENT SET
- K861311 — GLUCOSE (HEXOKINASE) REAGENT SET
- K860216 — SGOT (AST) REAGENT SET
- K860477 — URIC ACID REAGNET SET (TRINDER)
- K860485 — SGPT (ALT) REAGENT SET (COLORIMETRIC)
- K860667 — ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET
- K860214 — TOTAL BILIRUBIN REAGENT SET
- K860348 — GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET
- K860478 — SERUM IRON & IRON BINDING REAGENT SET
- K860554 — SERUM LIPASE REAGENT SET (TURBIDIMETRIC)
- K860628 — INORGANIC PHOSPHORUS REAGENT SET
- K860476 — ACID PHOSPHATASE REAGENT SET
- K860475 — HEMOGLOBIN REAGENT SET
- K860349 — LACTATE DEHYDROGENASE (LDH) REAGENT SET
- K860530 — AMYLASE REAGENT SET (MODIFIED CARAWAY)
- K860420 — SICKLE CELL REAGENT SET
- K855164 — ENZYNATIC TRIGLYCERIDES REAGENT SET
- K860340 — SERUM ALBUMIN (BCG) REAGENT SET
- K860044 — CALCIUM (CPC) REAGENT SET
- K860096 — CPK REAGENT SET (COLORIMETRIC)
- K860142 — URIC ACID REAGENT SET (COLORIMETRIC)
- K860215 — MAGNESIUM REAGENT SET
- K860341 — TOTAL PROTEIN (BIURET) REAGENT SET
- K860351 — ALKALINE PHOSPHATASE REAGENT SET
- K860418 — CREATININE REAGENT SET
- K860419 — UREA NITROGEN REAGENT SET
- K860154 — BUN (ENZYMATIC BERTHELOT) REAGENT SET
- K855028 — TOTAL CHOLESTEROL REAGENT SET
- K854335 — GLUCOSE REAGENT SET (GOD/TRINDER)
Data sourced from openFDA. This site is unofficial and independent of the FDA.