Drg Instruments Gmbh
FRAUENBERGSTRASSE 18, MARBURG Hesse, DE
Registered product codes
97 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
3 on file
- TerminatedUnknown
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
View FDA record ↗ - TerminatedUnknown
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.
View FDA record ↗ - TerminatedUnknown
Lower recovery of salivary estradiol levels due to poor differentiation between kit Standard 0 and Standard 1.
View FDA record ↗
Compliance history
Matched by FEI 3002800697.
FDA inspections
2 on file
- Official Action Indicated (OAI)Nov 7, 2024
Compliance: Devices · Citations posted
- Official Action Indicated (OAI)Nov 7, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.17Nov 7, 2024
Lack of Written MDR Procedures
- 21 CFR 820.100(a)Nov 7, 2024
Lack of or inadequate procedures
- 21 CFR 820.198(e)Nov 7, 2024
Records of complaint investigation - UDI
- 21 CFR 830.300(a)Nov 7, 2024
Devices subject to device identification GUDID data submission requirements.
Compliance actions
1 on file
Import refusals
19 on file
Top refusal reasons
Compare to industry ↗- Division of Northeast Imports (DNEI)Jul 22, 2025
82DHR \ SYSTEM, TEST, RHEUMATOID FACTOR
- Division of Northeast Imports (DNEI)Jul 9, 2025
75JKC \ RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)
- Division of Northeast Imports (DNEI)Jul 9, 2025
82KTO \ REAGENT, IMMUNOASSAY, IGG
- Division of Northeast Imports (DNEI)Jul 8, 2025
83LJC \ ENZYME LINKED IMMUNOABSORBENT ASSAY, (CHLAMYDIAE GROUP)
- Division of Northeast Imports (DNEI)Jul 8, 2025
75CIZ \ RADIOIMMUNOASSAY, ANDROSTENEDIONE
- Division of Northeast Imports (DNEI)Jul 8, 2025
75CEC \ RADIOIMMUNOASSAY, FREE THYROXINE
- Division of Northeast Imports (DNEI)Jul 8, 2025
83MYF \ ENZYME LINKED IMMUNOSORBENT ASSAY HERPES SIMPLEX VIRUS, HSV-2
- Division of Northeast Imports (DNEI)Jul 8, 2025
83MYF \ ENZYME LINKED IMMUNOSORBENT ASSAY HERPES SIMPLEX VIRUS, HSV-2
- Division of Northeast Imports (DNEI)Jul 8, 2025
75CJM \ RADIOIMMUNOASSAY, ALDOSTERONE
- Division of Northeast Imports (DNEI)Jul 8, 2025
82KTO \ REAGENT, IMMUNOASSAY, IGG
- Division of Northeast Imports (DNEI)Jul 8, 2025
82KTO \ REAGENT, IMMUNOASSAY, IGG
- Division of Northeast Imports (DNEI)Jul 8, 2025
82KTO \ REAGENT, IMMUNOASSAY, IGG
- Division of Northeast Imports (DNEI)Jul 8, 2025
82KTO \ REAGENT, IMMUNOASSAY, IGG
- Division of Northeast Imports (DNEI)Jul 8, 2025
83MYL \ ASSAY, ENZYME LINKED IMMUNOSORBENT, PARVOVIRUS B19 IGG
- Division of Northeast Imports (DNEI)Jul 3, 2025
83LGD \ ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
- Division of Northeast Imports (DNEI)Jul 3, 2025
83LFZ \ ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
- Division of Northeast Imports (DNEI)Jul 3, 2025
83MXJ \ ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-1
- Division of Northeast Imports (DNEI)Jul 3, 2025
83MYF \ ENZYME LINKED IMMUNOSORBENT ASSAY HERPES SIMPLEX VIRUS, HSV-2
- Division of Northeast Imports (DNEI)May 8, 2025
75NHG \ ENZYME IMMUNOASSAY, CORTISOL, SALIVARY