Nichols Institute Diagnostics

Entity profile compiled from public source records

Public Record Profile Registrations: 0 510(k) filings: 1 Recalls: 2

Known Identifiers & Locations

FEI Numbers 2050095
Owner Operator Numbers N/A
Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (1)

Submission # Device Name Decision Date Decision Description Action
K002888 NICHOLS ADVANTAGE THYROGLOB 2000-10-20 Substantially Equivalent View Details

FDA Recall History (2)

Recall # Product Description Initiation Date Status Action
Z-0006-06 Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052) Reason: Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months. 2005-08-31 Terminated View Details
Z-0007-06 Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039) Reason: Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months. 2005-08-31 Terminated View Details

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.

Account Required Full available specs will require a free AvaSpecs account.