ClearanceBrief
Panels › Pathology › Product code MVU · Class 1

Reagents, Specific, Analyte

Regulation 864.4020

0510(k)s in 12 months (0 all time)
1recalls in 12 months (43 all time)
0recalls that name a 510(k)
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Top companies in MVU

DateFirm and productCodeLinked 510(k)
Dec 1, 2025GET TESTED INTERNATIONAL AB
Herpes (HSV-1 & HSV-2) Test
Open, Classified
MVUNone listed
Nov 22, 2024Kreatech Biotechnology Bv
Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
Open, Classified
MVUNone listed
Feb 26, 2024Abbott Molecular, Inc.
In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis TelVysion 1p SpectrumGree
Open, Classified
MVUNone listed
Jan 5, 2024Becton, Dickinson and Company, BD Biosciences
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Open, Classified
MVUNone listed
Jul 20, 2023Cytocell Ltd.
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Open, Classified
MVUNone listed
Jul 20, 2023Cytocell Ltd.
RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Open, Classified
MVUNone listed
Dec 1, 2022Cytocell Ltd.
CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on ch
Terminated
MVUNone listed
Nov 30, 2022Cytocell Ltd.
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
Terminated
MVUNone listed
Mar 25, 2022Becton, Dickinson and Company, BD Biosciences
BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in
Open, Classified
MVUNone listed
Mar 25, 2022Becton, Dickinson and Company, BD Biosciences
BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recognizes the kappa light chains of human immunoglobulins. Anti-Kappa is used for in
Open, Classified
MVUNone listed
Feb 4, 2022Cytocell Ltd.
TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
Terminated
MVUNone listed
Jul 22, 2021Becton, Dickinson and Company, BD Biosciences
BD" Mouse IgG2a Isotype Control APC X39 ASR
Terminated
MVUNone listed
May 27, 2021Cytocell Ltd.
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Terminated
MVUNone listed
May 27, 2021Cell Marque Corporation
Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513
Terminated
MVUNone listed
May 27, 2021Cell Marque Corporation
Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
Terminated
MVUNone listed
May 17, 2021Cytocell Ltd.
CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
Terminated
MVUNone listed
Mar 19, 2021Cytocell Ltd.
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Open, Classified
MVUNone listed
Dec 22, 2020Cytocell Ltd.
Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 g
Terminated
MVUNone listed
Jul 17, 2020Cytocell Ltd.
Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 mark
Terminated
MVUNone listed
May 13, 2020Becton, Dickinson and Company, BD Biosciences
Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic
Terminated
MVUNone listed
Jun 19, 2019Cytocell Ltd.
Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319
Terminated
MVUNone listed
Mar 15, 2019Cytocell Ltd.
Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
Terminated
MVUNone listed
Jun 1, 2017Cell Marque Corporation
HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18; Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Terminated
MVUNone listed
Jun 1, 2017Cell Marque Corporation
CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Terminated
MVUNone listed
Jun 1, 2017Cell Marque Corporation
SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Terminated
MVUNone listed
Jun 1, 2017Cell Marque Corporation
Estrogen Receptor (SP1) 7.0 mL Catalog number 249R-18; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Terminated
MVUNone listed
Jun 1, 2017Cell Marque Corporation
Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog number 249R-16 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Terminated
MVUNone listed
Sep 21, 2016Becton, Dickinson and Company, BD Biosciences
CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig)
Terminated
MVUNone listed
Jan 25, 2016Becton, Dickinson and Company, BD Biosciences
BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. Product Usage: Analyte Specific Reagent. FMC7 is intended for in vitro
Terminated
MVUNone listed
Jan 11, 2016Becton, Dickinson and Company, BD Biosciences
FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent.
Terminated
MVUNone listed
Oct 30, 2015Becton, Dickinson and Company, BD Biosciences
BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected stain
Terminated
MVUNone listed
Aug 24, 2015Becton, Dickinson and Company, BD Biosciences
BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK ce
Terminated
MVUNone listed
Apr 2, 2015BD Biosciences, Systems & Reagents
CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
Terminated
MVUNone listed
Jan 20, 2015BD Biosciences, Systems & Reagents
Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
Terminated
MVUNone listed
May 1, 2014BD Biosciences, Systems & Reagents
Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting.
Terminated
MVUNone listed
Apr 23, 2014Abbott Molecular
The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chrom
Terminated
MVUNone listed
Jan 16, 2014Lab Vision Corporation
Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park R
Terminated
MVUNone listed
Feb 17, 2012Phadia US Inc
ImmunoCAP Allergen Ri206, Cockroach American, Periplaneta americana It is an analyte specific reagent and no intended use, however, it is typically used in vitro quantitive assay for the measurement
Terminated
MVUNone listed
Dec 2, 2010BD Biosciences, Systems & Reagents
BD Bioscience CD45 APC-H7 Analyte Specific Reagent, manufactured by BD Biosciences, San Jose, CA. CD45 recognizes members of the T200 family of human leucocyte antigens with molecular mass of 180 to
Terminated
MVUNone listed
Mar 13, 2007Abbott Molecular
Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list
Terminated
MVUNone listed
Aug 29, 2006Biogenex Laboratories
BioGenex brand Hepatitis B Virus Surface Antigen Antibody, Cat. No. AM364-5M and MU364-UC, Product is distributed by BioGenex Laboratories, 4600 Norris Canyon Rd., San Ramon, CA 94583
Terminated
MVUNone listed
Aug 29, 2006Biogenex Laboratories
BioGenex brand Hepatitis B Virus Core Antigen Antibody, Cat. No. AR082-5R and PU082-UP, Product is distributed by BioGenex Laboratories, 4600 Norris Canyon Rd., San Ramon, CA 94583
Terminated
MVUNone listed
Jul 13, 2005Roche Molecular Systems Inc
TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS).
Terminated
MVUNone listed

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