Product code LDT
LDT
0510(k)s in 12 months (0 all time)
0recalls in 12 months (6 all time)
1recalls that name a 510(k)
Top companies in LDT
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter Inc. | 0 | 2 |
| BioMerieux SA | 0 | 1 |
| Celera Corporation | 0 | 1 |
| Dako Denmark A/S | 0 | 1 |
| Dako North America Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2016 | BioMerieux SA NucliSENS easyMAG Magnetic Silica
The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which mention these products in their User Man Terminated |
LDT | None listed |
| Jul 20, 2016 | Beckman Coulter Inc. The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are affected by this recall. Terminated |
LDT | None listed |
| Jul 6, 2016 | Dako Denmark A/S EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004.
Intended for use in immunohistochemistry together with Autostainer Link Instruments. Terminated |
LDT | None listed |
| Nov 5, 2015 | Dako North America Inc. EnVision FLEX/HRP visualization reagent found in the following kits:
EnVision FLEX, High pH (Link)
EnVision FLEX+, Mouse, High pH (Link)
EnVision FLEX Mini Kit, High pH (Link)
EnVision FLEX, High pH ( Terminated |
LDT | None listed |
| Aug 26, 2013 | Celera Corporation OLA Buffer
For Laboratory Use;
Contents: 1 tube with buffered solution containing
MgCl2 (80 M) and KCL (300 M. 10.0ml.)
PN: 50003300;
Store at d - 15C.
Product Usage: General Purpose Reagent for Terminated |
LDT | None listed |
| Apr 20, 2011 | Beckman Coulter Inc. IMMAGE Immunochemistry Systems Wash Solution Part Number: 447060
The IMMAGE Immunochemistry Systems Wash Solution is intended for use with IMMAGE Immunochemistry Systems and reagents for the quantit Terminated |
LDT | K962294 |
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