Vysis
Cri-du-Chat Region Probe - Vysis LSI D5S23, D5S721 SpectrumGreen Probes
6manufacturers in China registered for this device type
248catalogue numbers in this listing
3recalls 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 | Abbott Molecular, Inc., United States |
|---|---|
| FDA product code | MVU |
| Device type | Reagents, Specific, Analyte |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4020 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2015-03-20 |
| Record revised | 2025-05-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -25 to -15 °C; Special storage condition: Store in Dark |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01N24-022 | In distribution | |
| 05J78-001 | In distribution | |
| 06J37-027 | In distribution | |
| 05J10-033 | In distribution | |
| 01N79-022 | In distribution | |
| 05J15-011 | In distribution | |
| 01N79-020 | In distribution | |
| 06J96-001 | In distribution | |
| 08N21-020 | In distribution | |
| 05J70-001 | In distribution | |
| 05J73-001 | In distribution | |
| 05J25-003 | In distribution | |
| 07J72-001 | In distribution | |
| 08N31-020 | In distribution | |
| 04N29-020 | In distribution | |
| 07J71-001 | In distribution | |
| 05J52-011 | In distribution | |
| 05J85-001 | In distribution | |
| 05J43-011 | In distribution | |
| 05J93-003 | In distribution | |
| 05J79-011 | In distribution | |
| 06J36-001 | In distribution | |
| 06J39-036 | In distribution | |
| 05J08-035 | In distribution | |
| 05J51-003 | In distribution | |
| 05J84-004 | In distribution | |
| 05J48-012 | In distribution | |
| 05J04-081 | In distribution | |
| 05J04-027 | In distribution | |
| 05J41-001 | In distribution | |
| 05J10-051 | In distribution | |
| 05J80-011 | In distribution | |
| 05J82-010 | In distribution | |
| 05J03-030 | In distribution | |
| 05J03-013 | In distribution | |
| 05J03-021 | In distribution | |
| 06J54-021 | In distribution | |
| 07J75-001 | In distribution | |
| 09N23-030 | In distribution | |
| 05J67-002 | In distribution | |
| 08N05-020 | In distribution | |
| 05J32-086 | In distribution | |
| 05J20-035 | In distribution | |
| 02N11-030 | In distribution | |
| 05J84-010 | In distribution | |
| 05J04-090 | In distribution | |
| 05J04-029 | In distribution | |
| 06N68-001 | In distribution | |
| 08N43-030 | In distribution | |
| 05J23-070 | In distribution | |
| 05J04-033 | In distribution | |
| 05J03-014 | In distribution | |
| 05J04-026 | In distribution | |
| 06J36-021 | In distribution | |
| 06J36-097 | In distribution | |
| 06J54-019 | In distribution | |
| 06J37-025 | In distribution | |
| 05J48-007 | In distribution | |
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| 06N09-001 | In distribution | |
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| 01N23-020 | In distribution | |
| 07N70-020 | In distribution | |
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| 06N70-001 | In distribution | |
| 08L79-050 | In distribution | |
| 05J93-001 | In distribution | |
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| 08N07-020 | In distribution | |
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| 06J37-022 | In distribution | |
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| 06J37-021 | In distribution | |
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| 05J09-033 | In distribution | |
| 07J86-011 | In distribution | |
| 05J03-027 | In distribution | |
| 05J03-026 | In distribution | |
| 07J77-003 | In distribution | |
| 05J03-015 | In distribution | |
| 05J96-003 | In distribution | |
| 05J03-022 | In distribution | |
| 06J36-014 | In distribution | |
| 06J54-020 | In distribution | |
| 05J04-094 | In distribution | |
| 06J36-013 | In distribution | |
| 05J04-030 | In distribution | |
| 05J77-001 | In distribution | |
| 05J19-014 | In distribution | |
| 05J03-096 | In distribution | |
| 05J21-020 | In distribution | |
| 06J36-016 | In distribution | |
| 05J75-001 | In distribution | |
| 06J36-030 | In distribution | |
| 02N20-020 | In distribution | |
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| 06J37-020 | In distribution | |
| 05J48-011 | In distribution | |
| 02N21-020 | In distribution | |
| 05J84-001 | In distribution | |
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| 06J54-027 | In distribution | |
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| 05J04-096 | In distribution | |
| 06J36-019 | In distribution | |
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| 01N12-010 | In distribution | |
| 01N78-020 | In distribution | |
| 06J37-018 | In distribution | |
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| 05J60-001 | In distribution | |
| 04N30-020 | In distribution | |
| 05J03-033 | In distribution | |
| 05J09-034 | In distribution | |
| 05J82-001 | In distribution | |
| 08N64-020 | In distribution | |
| 05J61-001 | In distribution | |
| 04N33-020 | In distribution | |
| 05J28-005 | In distribution | |
| 05J71-001 | In distribution | |
| 05J03-099 | In distribution | |
| 05J84-006 | In distribution | |
| 05J21-028 | In distribution | |
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| 06N22-010 | In distribution | |
| 01N79-021 | In distribution | |
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| 08N64-030 | In distribution | |
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| 06J38-027 | In distribution | |
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| 05J44-011 | In distribution | |
| 06J37-019 | In distribution | |
| 05J04-097 | In distribution | |
| 05J04-092 | In distribution | |
| 06J36-025 | In distribution | |
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| 05J22-015 | In distribution | |
| 09N25-020 | In distribution | |
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| 07J74-003 | In distribution | |
| 02N23-020 | In distribution | |
| 05J51-001 | In distribution | |
| 05J48-013 | In distribution | |
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| 01N17-020 | In distribution | |
| 01N88-030 | In distribution | |
| 05J86-011 | In distribution | |
| 05J10-034 | In distribution | |
| 06J37-016 | In distribution | |
| 06J36-037 | In distribution | |
| 01N79-023 | In distribution | |
| 06J37-087 | In distribution | |
| 05N97-010 | In distribution | |
| 05J21-030 | In distribution | |
| 04N31-020 | In distribution | |
| 05J62-001 | In distribution | |
| 07N73-020 | In distribution | |
| 05J84-009 | In distribution | |
| 05J10-026 | In distribution | |
| 07J65-003 | In distribution | |
| 05J03-090 | In distribution | |
| 01N24-021 | In distribution | |
| 05J04-098 | In distribution | |
| 07J65-004 | In distribution | |
| 05J03-091 | In distribution | |
| 05J03-098 | In distribution | |
| 08L79-020 | In distribution | |
| 05J09-028 | In distribution | |
| 09N24-020 | In distribution | |
| 05N24-010 | In distribution | |
| 06J37-014 | In distribution | |
| 05J04-099 | In distribution | |
| 05J31-085 | In distribution | |
| 06J54-014 | In distribution | |
| 07J73-001 | In distribution | |
| 05J27-007 | In distribution | |
| 05J05-001 | In distribution | |
| 05J04-083 | In distribution | |
| 05J72-001 | In distribution | |
| 05J88-001 | In distribution | |
| 05J08-028 | In distribution | |
| 05J27-089 | In distribution | |
| 06N05-001 | In distribution | |
| 05J74-001 | In distribution | |
| 06J54-016 | In distribution | |
| 06N61-010 | In distribution | |
| 05J48-001 | In distribution | |
| 04N32-020 | In distribution | |
| 05J47-011 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CytoCell myProbes | Cytocell Limited | 1,286 |
| Beckmancoulter | Immunotech Corp. | 678 |
| CytoCell | Cytocell Limited | 587 |
| MetaSystems Probes | Metasystems Probes Gmbh | 529 |
| Reagents, Specific, Analyte | Becton, Dickinson AND Company | 288 |
| 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
2 of these are Class III. 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 |
|---|---|---|---|---|---|
| 2024-02-01 | Class III | Process control | Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers. | 7 kits | |
| 2013-03-28 | Class III | Packaging change control | 20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis CEP 4 (Alpha Satellite) SG Probe, 20u, (part 32-112004 lot 438814), instead of the expected CEP 8 probe. | 20 kits | 2016-03-08 |
| 2006-12-22 | Not classified | Other | The LSI D13S319 SO/13q34 SA/CEP 12 SG probe of the two mixture DNA-Probe was contaminated with LSI ATM SG/p53 SO probe. This contamination would result in 10 FISH signals in each normal cell rather than the expected 6 FISH signals in each | 109 probe sets | 2008-04-17 |
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.