DRG Instruments GmbH · 89-08 · GERMANY
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
- 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
- Address
- Frauenbergstr. 18 , Marburg, Hassia GERMANY verified
- Date published
- 10/25/2017 verified
- Product code
- 75 N - - HG Enzyme Immunoassay, Cortisol, Salivary | 75 O - - TV Research use only/clinical chemistry devices each item verified
- 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) each item verified
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:
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html