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Quality Control Slides
FDA product code LJG · Class 1 · Microbiology
1,043
Registered devices
0
Adverse events
5
Recalls
27
510(k) clearances
Devices with this code
TLE1 Control Slides — BIO SB, INC.Islet 1/ISL1 Control Slides — BIO SB, INC.MyoD1 Control Slides — BIO SB, INC.S100P Control Slides — BIO SB, INC.Neurofilament control slides — BIO SB, INC.Cytokeratin HMW 34BE12 Control Slides — BIO SB, INC.Tinto BRAF V600E RMab — BIO SB, INC.Calponin Control Slides — BIO SB, INC.Mycobacterium tuberculosis Control Slides — BIO SB, INC.Mesothelial Cell Control Slides — BIO SB, INC.S100A1 Control Slides — BIO SB, INC.Alpha-Tec Systems — Alpha-TEC Systems, Inc.N/A — Scientific Device Laboratory, Inc.CD41/Integrin alpha IIb Control Slides — BIO SB, INC.Microbiology Slides — MICROBIOLOGICS INC.VEGF control slides — BIO SB, INC.Estrogen Receptor Control Slides — BIO SB, INC.MSH6 Control Slides — BIO SB, INC.Cytokeratin 7 & CDX2 control slides — BIO SB, INC.Lysozyme control slides — BIO SB, INC.11-core Human Normal TMA Control Slides — BIO SB, INC.GFAP Control Slides — BIO SB, INC.Calcitonin Control Slides — BIO SB, INC.Actin Smooth Muscle Control Slides — BIO SB, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-03-18 | Opgen Inc | May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test |
| 2018-05-14 | Opgen Inc | Possible diminished performance prior to its established expiration date. |
| 2013-02-11 | Microbiologics Inc | Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL42-10 and KWIK-QC Mycobacterium, SL43-10. These products are b |
| 2012-05-29 | Microbiologics Inc | Microbiologics is recalling a number of lots of KWIK-QC Gram Stain Slides. This product gram negative control organism (E.coli) is not properly fixated on the |
| 2003-11-03 | Remel, Inc. | Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area |
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