DRG Instruments GmbH
MARBURG Hesse, DE
DRG INSTRUMENTS GMBH appears in FDA device records in MARBURG Hesse, DE. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002800697 | 3002800697 | DRG INSTRUMENTS GMBH | FRAUENBERGSTRASSE 18, MARBURG Hesse D-35039 DE | 2026 | and 89 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
- GPFAntigen, Agglutinating, Echinococcus Spp.
- GOXAntigen, B. Pertussis
- JWTAntigen, Cf, Aspergillus Spp.
- GNHAntigen, Fluorescent Antibody Test, Schistosoma Mansoni
- KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
- GMOAntigen, Latex Agglutination, Entamoeba Histolytica & Rel. Spp.
- GRYAntigens, All, Leptospira Spp.
- GODAntigens, Cf (Including Cf Control), Adenovirus 1-33
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
- GNWAntisera, Cf, Influenza Virus A, B, C
- GNYAntisera, Fluorescent, Adenovirus 1-33
- GPRAntiserum, Cf, Q Fever
- GOSAntiserum, Fluorescent, C. Diphtheriae
- DPAApparatus, General Use, Thin Layer Chromatography
- GGTAssay, Erythropoietin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DGCIge, Antigen, Antiserum, Control
- JMRImmunochemical, Lysozyme (Muramidase)
- JNLImmunochemical, Thyroglobulin Autoantibody
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- DEGLactoferrin, Antigen, Antiserum, Control
- JMQM. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- KHQRadioassay, Triiodothyronine Uptake
- JLXRadioimmunoassay, 17-Hydroxyprogesterone
- CKGRadioimmunoassay, Acth
- CIZRadioimmunoassay, Androstenedione
- JKDRadioimmunoassay, C-Peptides Of Proinsulin
- JKRRadioimmunoassay, Calcitonin
- CHARadioimmunoassay, Corticosterone
- CGRRadioimmunoassay, Cortisol
- JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- CHPRadioimmunoassay, Estradiol
- CGIRadioimmunoassay, Estriol
- CGFRadioimmunoassay, Estrone
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CFLRadioimmunoassay, Human Growth Hormone
- CFPRadioimmunoassay, Immunoreactive Insulin
- CEPRadioimmunoassay, Luteinizing Hormone
- CEWRadioimmunoassay, Parathyroid Hormone
- JNGRadioimmunoassay, Pregnenolone
- JLSRadioimmunoassay, Progesterone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- CZSRetinol-Binding Protein, Antigen, Antiserum, Control
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- DFQSperm, Antigen, Antiserum, Control
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- DHRSystem, Test, Rheumatoid Factor
- JZOSystem, Test, Thyroid Autoantibody
- DDCThyroglobulin, Antigen, Antiserum, Control
- IAFWright'S Stain
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2410-2019 | DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic | Salivary Progesterone assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit {< 20 pg/ml) were assayed and producing a significantly lower result. | Class II | Terminated | |
| Z-2159-2019 | DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means | Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were assayed significantly lower | Class II | Terminated | |
| Z-2836-2018 | Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva. | Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain