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)
Top companies in MVU
| Company | 510(k)s | Recalls |
|---|---|---|
| Cytocell Ltd. | 0 | 12 |
| Becton, Dickinson and Company, BD Biosciences | 0 | 10 |
| Cell Marque Corporation | 0 | 7 |
| BD Biosciences, Systems & Reagents | 0 | 4 |
| Abbott Molecular | 0 | 3 |
| Biogenex Laboratories | 0 | 2 |
| GET TESTED INTERNATIONAL AB | 0 | 1 |
| Kreatech Biotechnology Bv | 0 | 1 |
| Lab Vision Corporation | 0 | 1 |
| Phadia US Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Herpes (HSV-1 & HSV-2) Test Open, Classified |
MVU | None listed |
| Nov 22, 2024 | Kreatech 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 |
MVU | None listed |
| Feb 26, 2024 | Abbott 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 |
MVU | None listed |
| Jan 5, 2024 | Becton, Dickinson and Company, BD Biosciences CD11b APC: ASR, REF: 340936, and CE, REF: 333143 Open, Classified |
MVU | None listed |
| Jul 20, 2023 | Cytocell 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 |
MVU | None listed |
| Jul 20, 2023 | Cytocell 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 |
MVU | None listed |
| Dec 1, 2022 | Cytocell 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 |
MVU | None listed |
| Nov 30, 2022 | Cytocell Ltd. CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent
Ref: MPD39782 Terminated |
MVU | None listed |
| Mar 25, 2022 | Becton, 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 |
MVU | None listed |
| Mar 25, 2022 | Becton, 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 |
MVU | None listed |
| Feb 4, 2022 | Cytocell 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 |
MVU | None listed |
| Jul 22, 2021 | Becton, Dickinson and Company, BD Biosciences BD" Mouse IgG2a Isotype Control APC X39 ASR Terminated |
MVU | None listed |
| May 27, 2021 | Cytocell Ltd. Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's) Terminated |
MVU | None listed |
| May 27, 2021 | Cell Marque Corporation Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513 Terminated |
MVU | None listed |
| May 27, 2021 | Cell Marque Corporation Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798 Terminated |
MVU | None listed |
| May 17, 2021 | Cytocell Ltd. CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics Terminated |
MVU | None listed |
| Mar 19, 2021 | Cytocell Ltd. Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481 Open, Classified |
MVU | None listed |
| Dec 22, 2020 | Cytocell 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 |
MVU | None listed |
| Jul 17, 2020 | Cytocell 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 |
MVU | None listed |
| May 13, 2020 | Becton, 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 |
MVU | None listed |
| Jun 19, 2019 | Cytocell 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 |
MVU | None listed |
| Mar 15, 2019 | Cytocell Ltd. Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent. Terminated |
MVU | None listed |
| Jun 1, 2017 | Cell 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 |
MVU | None listed |
| Jun 1, 2017 | Cell 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 |
MVU | None listed |
| Jun 1, 2017 | Cell 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 |
MVU | None listed |
| Jun 1, 2017 | Cell Marque Corporation Estrogen Receptor (SP1)
7.0 mL Catalog number 249R-18;
Hematology - Analyte Specific Reagent
In vitro diagnostic use - Analyte Specific Reagent Terminated |
MVU | None listed |
| Jun 1, 2017 | Cell 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 |
MVU | None listed |
| Sep 21, 2016 | Becton, 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 |
MVU | None listed |
| Jan 25, 2016 | Becton, 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 |
MVU | None listed |
| Jan 11, 2016 | Becton, Dickinson and Company, BD Biosciences FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent. Terminated |
MVU | None listed |
| Oct 30, 2015 | Becton, 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 |
MVU | None listed |
| Aug 24, 2015 | Becton, 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 |
MVU | None listed |
| Apr 2, 2015 | BD Biosciences, Systems & Reagents CD123 (9F5) PE
Catalog number 649453
Analyte Specific Reagent Terminated |
MVU | None listed |
| Jan 20, 2015 | BD Biosciences, Systems & Reagents Anti-Lambda APC-H7, Catalog Number 656157.
Product Usage:
Intended for in vitro flow cytometric immunophenotyping of hematologic disorders. Terminated |
MVU | None listed |
| May 1, 2014 | BD 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 |
MVU | None listed |
| Apr 23, 2014 | Abbott 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 |
MVU | None listed |
| Jan 16, 2014 | Lab 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 |
MVU | None listed |
| Feb 17, 2012 | Phadia 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 |
MVU | None listed |
| Dec 2, 2010 | BD 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 |
MVU | None listed |
| Mar 13, 2007 | Abbott 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 |
MVU | None listed |
| Aug 29, 2006 | Biogenex 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 |
MVU | None listed |
| Aug 29, 2006 | Biogenex 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 |
MVU | None listed |
| Jul 13, 2005 | Roche Molecular Systems Inc TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS). Terminated |
MVU | None listed |
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