6 results
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55ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA
FDA Enforcement
Class III
·Ongoing·DRG International, Inc.·August 13, 2025
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
FDA Enforcement
Class II
·Ongoing·DRG International, Inc.·January 22, 2025
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
FDA Enforcement
Class III
·Ongoing·DRG International, Inc.·November 6, 2024
Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.
FDA Enforcement
Class III
·Ongoing·DRG International, Inc.·August 21, 2024
Total Thyroxine (T4) ELISA; REF EIA-1781
FDA Enforcement
Class II
·Ongoing·DRG International, Inc.·December 8, 2021
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
FDA Enforcement
Class II
·Terminated·DRG International, Inc.·April 13, 2022