Panels › Clinical Chemistry › Product code CIX · Class 2
Bromcresol Green Dye-Binding, Albumin
Regulation 862.1035
1510(k)s in 12 months (120 all time)
0recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in CIX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 16, 2024 | Ortho-Clinical Diagnostics, Inc. The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide f Open, Classified |
CIX | None listed |
| Aug 27, 2020 | Roche Diagnostics Operations, Inc. Albumin Gen.2, Catalog 05166861190 Terminated |
CIX | K033009 |
| Oct 16, 2019 | Roche Diagnostics Operations, Inc. Roche Diagnostics cobas Integra Albumin Gen.2
Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi co Terminated |
CIX | K033009 |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211
VITROS ALB Slides quantitatively measure (ALB) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 C Terminated |
CIX | K023875 K812030 |
| Apr 18, 2012 | Abbott Laboratories Inc. Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21
Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX
The Albumin BCG assay is used for the quantitation of albumin in human serum Terminated |
CIX | K981758 |
| Oct 9, 2008 | Roche Diagnostics Corp. Roche Diagnostics ALBT2, Tina-quant Albumin Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04469658190.
An in-vitro diagnostic reagent system intended for use on COBAS Terminated |
CIX | K033009 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.