Chromsystems Instruments & Chemicals GmbH
Gräfelfing Bavaria, DE
CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH appears in FDA device records in Gräfelfing Bavaria, DE. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Chromsystems Instruments & Chemicals GmbH in 2009.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003951180 | 3003951180 | CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH | Am Haag 12, Gräfelfing Bavaria 82166 DE | 2026 | and 9 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)
- CDAAcid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
- JOAAcid, Trifluoroacetic, Vitamin A, Hexane Extraction
- CDFAcid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
- DKCAlcohol Control Materials
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- DLJCalibrators, Drug Specific
- DNNCalibrators, Ethyl Alcohol
- CHQChromatographic/Fluorometric Method, Catecholamines
- KZRChromatography (Liquid, Gel), Clinical Use
- LEQDetectors, Electrochemical, Liquid Chromatography
- LASDrug Specific Control Materials
- MLMEnzyme Immunoassay, Tracrolimus
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- JKJFluorometric Measurement, Porphyrins
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JJWUrinalysis Controls (Assayed And Unassayed)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1337-2022 | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II | Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products. | Class II | Terminated | |
| Z-1336-2022 | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I | Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products. | Class II | Terminated | |
| Z-0539-2021 | MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder. | XXX | Class II | Terminated | |
| Z-0538-2021 | MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder. | XXX | Class II | Terminated | |
| Z-0537-2021 | MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder. | Products do not meet stability criteria and may impact results. | Class II | Terminated | |
| Z-0536-2021 | 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder. | Products do not meet stability criteria and may impact results. | Class II | Terminated | |
| Z-0523-2021 | MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels. | Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone. | Class II | Completed | |
| Z-0522-2021 | MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels. | Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone. | Class II | Completed | |
| Z-0521-2021 | 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels. | Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone. | Class II | Completed |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Chromsystems Instruments & Chemicals GmbH edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain