Macherey Nagel GmbH & Co. KG
DUEREN North Rhine-Westphalia, DE
MACHEREY-NAGEL GMBH & CO., KG. appears in FDA device records in DUEREN North Rhine-Westphalia, DE. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Macherey Nagel GmbH & Co. KG between 2005 and 2006. The busiest year on record is 2005, with 1. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 4580 | 4580 | MACHEREY-NAGEL GMBH & CO., KG. | Valencienner Str. 11, DUEREN North Rhine-Westphalia 52355 DE | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
- KQOAutomated Urinalysis System
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- JIOBlood, Occult, Colorimetric, In Urine
- JIPBlood, Occult, Enzymatic Method, In Urine
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- JRERefractometer For Clinical Use
- KSLSolution, Copper Sulfate For Specific Gravity Determinations
- LJXTest, Urine Leukocyte
- JLLTubeless Analysis, Gastric Acidity
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1834-2024 | Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique. | The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the test strips. The issue was identified by a consumer by way of a Henry Schein Inc. (HSI) customer complaint. This problem can potentially result in the possibility that the parameter leucocytes (a non-specific marker for urinary track infections and an indicator for inflammatory renal processes) is interpreted instrumentally as a false negative. The following HSI item number and lot number were affected: Urispec 11-Way, #102-2285, LOT 65402. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain