Reference Source

DRG Instruments GmbH · 89-08 · GERMANY

For DRG Instruments GmbH, import alert is 89-08; country is GERMANY; 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)"; 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 2026-09-30.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

DRG Instruments GmbH Date Published : 10/25/2017 Frauenbergstr. 18 , Marburg, Hassia GERMANY

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code and Product

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:

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

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