# DRG Instruments GmbH · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

For DRG Instruments GmbH · 89-08 · GERMANY, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is GERMANY; product is Salivary Cortisol ELISA/ CORTISOL (SALIVARY) ELISA and Salivary Cortisol ELISA/ CORTISOL (SALIVARY) ELISA Research Use Only (RUO) | Salivary Cortisol ELISA/ CORTISOL (SALIVARY) ELISA and Salivary Cortisol ELISA/ CORTISOL (SALIVARY) ELISA Research Use Only (RUO); product code is 75 N - - HG Enzyme Immunoassay, Cortisol, Salivary | 75 O - - TV Research use only/clinical chemistry devices; date published is 10/25/2017; address is Frauenbergstr. 18 , Marburg, Hassia GERMANY, verified against its source on 2026-09-16.

- **Firm:** DRG Instruments GmbH _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** GERMANY _(verified: appears in the quote below)_
- **Address:** Frauenbergstr. 18 , Marburg, Hassia GERMANY _(verified: appears in the quote below)_
- **Date published:** 10/25/2017 _(verified: appears in the quote below)_
- **Product code:** 75 N - - HG Enzyme Immunoassay, Cortisol, Salivary | 75 O - - TV Research use only/clinical chemistry devices _(verified: each item appears in the quote below)_
- **Product:** Salivary Cortisol ELISA/ CORTISOL (SALIVARY) ELISA and Salivary Cortisol ELISA/ CORTISOL (SALIVARY) ELISA Research Use Only (RUO) | Salivary Cortisol ELISA/ CORTISOL (SALIVARY) ELISA and Salivary Cortisol ELISA/ CORTISOL (SALIVARY) ELISA Research Use Only (RUO) _(verified: each item appears in the quote below)_

## What the source says

> DRG Instruments GmbH Date Published : 10/25/2017 Frauenbergstr. 18 , Marburg, Hassia GERMANY 75 N - - HG Enzyme Immunoassay, Cortisol, Salivary Date Published: 04/16/2025 Desc: Salivary Cortisol ELISA/ CORTISOL (SALIVARY) ELISA and Salivary Cortisol ELISA/ CORTISOL (SALIVARY) ELISA Research Use Only (RUO) Notes: 75 O - - TV Research use only/clinical chemistry devices Date Published: 04/16/2025 Desc: Salivary Cortisol ELISA/ CORTISOL (SALIVARY) ELISA and Salivary Cortisol ELISA/ CORTISOL (SALIVARY) ELISA Research Use Only (RUO) Notes:

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).