CytoCell
2qter Subtelomere Specific Probe non-polymorphic clone (Concentrated) (ASR)
6manufacturers in China registered for this device type
587catalogue numbers in this listing
12recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Hunan (1), Henan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Henan Celnovte Biotechnology Co., Ltd. | Zhengzhou | Henan | Manufacturer | 8 |
| Phase Scientific (Shenzhen) Company Limited | Shenzhen | Guangdong | Repacker / relabeller | 8 |
| Shenzhen Dartmon Biotechnology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Shanghai ZJ BIO-Tech Co., Ltd. | Shanghai | Shanghai | Private-label distributor | 3 |
| Diaglogic Biolabs (Xiamen) Co., Ltd. | Xiamen | Fujian | Manufacturer | 1 |
Record
| Listed by | Cytocell Limited, United Kingdom |
|---|---|
| FDA product code | MVU |
| Device type | Reagents, Specific, Analyte |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4020 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-01 |
| Record revised | 2024-12-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store the probe and counterstain vials in the dark. Ensure that exposure of the probe and counterstain to laboratory lig; Storage environment temperature -25 to -15 °C |
| Distribution end date | 2024-12-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LPH513-A | In distribution | |
| LPS508-A | In distribution | |
| LPH042-A | In distribution | |
| LPS523-A | In distribution | |
| LPE001G-A | In distribution | |
| LPENOR-A | In distribution | |
| LPS528-SA | In distribution | |
| LPS519-A | In distribution | |
| LPE0XYC-A | In distribution | |
| LPH012-A | In distribution | |
| LPH501-A | In distribution | |
| LPT03PR-A | In distribution | |
| LPS017-A | In distribution | |
| LPE005G-A | In distribution | |
| LPE0XR-A | In distribution | |
| LPT11PG-A | In distribution | |
| LPH535-A | In distribution | |
| LPH025-A | In distribution | |
| LPH542-A | In distribution | |
| LPH541-A | In distribution | |
| LPH505-A | In distribution | |
| LPH012-A | In distribution | |
| LPH524-A | In distribution | |
| LPS012-A | In distribution | |
| LPH576-A | In distribution | |
| LPS034-A | In distribution | |
| LPH068-A | In distribution | |
| LPH542-A | In distribution | |
| LPH547-A | In distribution | |
| LPT07QR-A | In distribution | |
| LPU026-SA | In distribution | |
| LPE0YcR-A | In distribution | |
| LPT12QG-A | In distribution | |
| LPU013-A | In distribution | |
| LPU014-SA | In distribution | |
| LPE014G-A | In distribution | |
| LPU011-SA | In distribution | |
| LPH041-A | In distribution | |
| LPT08PR-A | In distribution | |
| LPU014-SA | In distribution | |
| LPT01QG-A | In distribution | |
| LPU009-A | In distribution | |
| LPU004-SA | In distribution | |
| LPU024-SA | In distribution | |
| LPH062-A | In distribution | |
| LPH020-A | In distribution | |
| LPT11PR-A | In distribution | |
| LPT16PR-A | In distribution | |
| LPT17PG-A | In distribution | |
| LPH575-A | In distribution | |
| LPS020-A | In distribution | |
| LPT19PG-A | In distribution | |
| LPH543-A | In distribution | |
| LPS034-A | In distribution | |
| LPE0YQG-A | In distribution | |
| LPS032-A | In distribution | |
| LPE017R-A | In distribution | |
| LPS509-A | In distribution | |
| LPT17PR-A | In distribution | |
| LPS006-A | In distribution | |
| LPS029-A | In distribution | |
| LPH519-A | In distribution | |
| LPT09PG-A | In distribution | |
| LPT12QR-A | In distribution | |
| LPE0YQR-A | In distribution | |
| LPH502-A | In distribution | |
| LPE0XG-A | In distribution | |
| LPH052-A | In distribution | |
| LPE012B-A | In distribution | |
| LPU019-A | In distribution | |
| LPH046-A | In distribution | |
| LPS014-A | In distribution | |
| LPH039-A | In distribution | |
| LPTXYPG-A | In distribution | |
| LPH014-A | In distribution | |
| LPE008R-A | In distribution | |
| LPU024-A | In distribution | |
| LPE0YQR-A | In distribution | |
| LPT10PG-A | In distribution | |
| LPT11QR-A | In distribution | |
| LPT01PR-A | In distribution | |
| LPE015G-A | In distribution | |
| LPS513-A | In distribution | |
| LPS031-A | In distribution | |
| LPH046-A | In distribution | |
| LPD504-A | In distribution | |
| LPT19QR-A | In distribution | |
| LPS519-A | In distribution | |
| LPE014G-A | In distribution | |
| LPS515-A | In distribution | |
| LPS522-A | In distribution | |
| LPS011-A | In distribution | |
| LPE017B-A | In distribution | |
| LPE012G-A | In distribution | |
| LPS009-A | In distribution | |
| LPH510-A | In distribution | |
| LPH527-A | In distribution | |
| LPH063-A | In distribution | |
| LPH038-A | In distribution | |
| LPH024-A | In distribution | |
| LPH510-A | In distribution | |
| LPH021-A | In distribution | |
| LPH511-A | In distribution | |
| LPS039-A | In distribution | |
| LPH533-A | In distribution | |
| LPS030-A | In distribution | |
| LPH044-A | In distribution | |
| LPU005-SA | In distribution | |
| LPH527-A | In distribution | |
| LPH006-A | In distribution | |
| LPU005-SA | In distribution | |
| LPE011G-A | In distribution | |
| LPT01PG-A | In distribution | |
| LPH017-A | In distribution | |
| LPH509-A | In distribution | |
| LPE012R-A | In distribution | |
| LPH052-A | In distribution | |
| LPH048-A | In distribution | |
| LPS521-A | In distribution | |
| LPS032-A | In distribution | |
| LPT12PR-A | In distribution | |
| LPH512-A | In distribution | |
| LPH027-A | In distribution | |
| LPH528-A | In distribution | |
| LPT01QR-A | In distribution | |
| LPT18QR-A | In distribution | |
| LPS012-A | In distribution | |
| LPT05QR-A | In distribution | |
| LPT05QG-A | In distribution | |
| LPT13QG-A | In distribution | |
| LPD501-A | In distribution | |
| LPE0XG-A | In distribution | |
| LPT03PG-A | In distribution | |
| LPS016-A | In distribution | |
| LPU019-A | In distribution | |
| LPH517-A | In distribution | |
| LPENOR-A | In distribution | |
| LPT09QG-A | In distribution | |
| LPH039-A | In distribution | |
| LPH007-A | In distribution | |
| LPT18PG-A | In distribution | |
| LPH525-A | In distribution | |
| LPH022-A | In distribution | |
| LPU011-A | In distribution | |
| LPU004-SA | In distribution | |
| LPE010G-A | In distribution | |
| LPS002-A | In distribution | |
| LPS509-A | In distribution | |
| LPH523-A | In distribution | |
| LPT06QG-A | In distribution | |
| LPH063-A | In distribution | |
| LPT21QG-A | In distribution | |
| LPT07PR-A | In distribution | |
| LPE017G-A | In distribution | |
| LPT17QG-A | In distribution | |
| LPE011R-A | In distribution | |
| LPS513-A | In distribution | |
| LPT07PR-A | In distribution | |
| LPT16PG-A | In distribution | |
| LPT08QR-A | In distribution | |
| LPH574-A | In distribution | |
| LPU014-A | In distribution | |
| LPH573-A | In distribution | |
| LPH507-A | In distribution | |
| LPS013-A | In distribution | |
| LPE0XR-A | In distribution | |
| LPT05QR-A | In distribution | |
| LPS033-A | In distribution | |
| LPH513-A | In distribution | |
| LPH508-A | In distribution | |
| LPH019-A | In distribution | |
| LPH514-A | In distribution | |
| LPH504-A | In distribution | |
| LPT07PG-A | In distribution | |
| LPT12PG-A | In distribution | |
| LPE006R-A | In distribution | |
| LPE017B-A | In distribution | |
| LPS022-A | In distribution | |
| LPU011-A | In distribution | |
| LPT11QG-A | In distribution | |
| LPH038-A | In distribution | |
| LPS512-A | In distribution | |
| LPU004-A | In distribution | |
| LPU004-A | In distribution | |
| LPH036-A | In distribution | |
| LPH522-A | In distribution | |
| LPU010-A | In distribution | |
| LPS520-A | In distribution | |
| LPS518-A | In distribution | |
| LPT10QR-A | In distribution | |
| LPTXYPR-A | In distribution | |
| LPT10QR-A | In distribution | |
| LPH035-A | In distribution | |
| LPT22QG-A | In distribution | |
| LPH512-A | In distribution | |
| LPH011-A | In distribution | |
| LPT20QR-A | In distribution | |
| LPU016-SA | In distribution | |
| LPH511-A | In distribution | |
| LPS035-A | In distribution | |
| LPS029-A | In distribution | |
| LPS522-A | In distribution | |
| LPH027-A | In distribution | |
| LPS508-A | In distribution | |
| LPU026-A | In distribution | |
| LPS526-A | In distribution | |
| LPH044-A | In distribution | |
| LPU025-SA | In distribution | |
| LPT04PG-A | In distribution | |
| LPT15QG-A | In distribution | |
| LPH545-A | In distribution | |
| LPH545-A | In distribution | |
| LPH529-A | In distribution | |
| LPT02PR-A | In distribution | |
| LPH020-A | In distribution | |
| LPS001-A | In distribution | |
| LPD503-A | In distribution | |
| LPH023-A | In distribution | |
| LPU019-SA | In distribution | |
| LPS003-A | In distribution | |
| LPE0YCG-A | In distribution | |
| LPS036-A | In distribution | |
| LPH045-A | In distribution | |
| LPD503-A | In distribution | |
| LPH006-A | In distribution | |
| LPH568-A | In distribution | |
| LPT05PG-A | In distribution | |
| LPH540-A | In distribution | |
| LPD502-A | In distribution | |
| LPE0YcR-A | In distribution | |
| LPH502-A | In distribution | |
| LPH533-A | In distribution | |
| LPS516-A | In distribution | |
| LPT02QNPG-A | In distribution | |
| LPH030-A | In distribution | |
| LPE018R-A | In distribution | |
| LPH567-A | In distribution | |
| LPH009-A | In distribution | |
| LPE008B-A | In distribution | |
| LPS518-A | In distribution | |
| LPS027-A | In distribution | |
| LPH526-A | In distribution | |
| LPS007-A | In distribution | |
| LPT05QG-A | In distribution | |
| LPE018G-A | In distribution | |
| LPTXYQR-A | In distribution | |
| LPH516-A | In distribution | |
| LPH026-A | In distribution | |
| LPS038-A | In distribution | |
| LPS017-A | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CytoCell myProbes | Cytocell Limited | 1,286 |
| Beckmancoulter | Immunotech Corp. | 678 |
| MetaSystems Probes | Metasystems Probes Gmbh | 529 |
| Reagents, Specific, Analyte | Becton, Dickinson AND Company | 288 |
| Vysis | Abbott Molecular, Inc. | 248 |
| Kreatech Fish probes | Leica Biosystems Newcastle Ltd | 197 |
| Horizon | Becton, Dickinson AND Company | 145 |
| goldFISH | Lumatas Biosystems, Inc | 119 |
| Immunalysis | Immunalysis Corporation | 97 |
| Invivoscribe | Invivoscribe, Inc. | 91 |
| Fort Worth Diagnostics | Fort Worth Diagnostics LLC | 88 |
| Novocastra™ | Leica Biosystems Newcastle Ltd | 29 |
Showing 12 of 3,073. All products under Reagents, Specific, Analyte
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cytocell Limited | UDI-DI | 2023-05-24 | Class II | Process control | DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. | 60 units |
| Cytocell Limited | UDI-DI | 2023-05-24 | Class II | Process control | DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. | 61 units |
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-10-27 | Class II | Under Investigation by firm | Device is mislabeled. The package insert for this ASR device contains a chromomap – an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the package insert is incorre | 2024-12-27 | |
| 2022-10-27 | Class II | Under Investigation by firm | An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates. | 3 units | 2024-12-27 |
| 2022-02-04 | Class III | Under Investigation by firm | May show unexpected locus specific signals in addition to those at 14q32. | 1 unit | 2024-11-06 |
| 2021-05-27 | Class II | Nonconforming Material/Component | May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34 | 23 units | 2022-05-09 |
| 2021-05-17 | Class II | Nonconforming Material/Component | The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13. | 50 | 2022-08-15 |
| 2021-03-19 | Class II | Under Investigation by firm | Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34. | 89 probes | |
| 2020-12-22 | Class II | Under Investigation by firm | Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a normal sample being reported as not normal in a resulting laboratory developed test (LDT) that utilizes the LPH511-A CRLF2 Distal Probe Green. | 72 | 2022-06-07 |
| 2020-07-17 | Class II | Under Investigation by firm | A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green. | 62 units | 2020-09-30 |
| 2019-04-26 | Class III | Labeling False and Misleading | There is an error in the chromomap on the package insert. | 400 | 2020-07-16 |
| 2019-03-15 | Class III | Labeling Change Control | There is an error in the chromomap included in the labeling for the product. | 19 | 2020-10-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.