Home › Device types › JJH
Clinical Sample Concentrator
FDA product code JJH · Class 1 · Clinical Chemistry
632
Registered devices
295
Adverse events
31
Recalls
15
510(k) clearances
Devices with this code
Vivaspin Filtrate — SARTORIUS STEDIM LAB LIMITEDTANBead Nucleic Acid Extractor — Taiwan Advanced Nanotech INC.ALLSHENG — HANGZHOU ALLSHENG INSTRUMENTS CO.,LTD.BIOER MagaBio plus Virus DNA/RNA Purification Kit II — Hangzhou Bioer Technology Co., Ltd.Prochem — VIVAPRODUCTS, INC.Macro & Micro-Test Viral DNA/RNA Kit — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.TANBead Nucleic Acid Extraction Kit — Taiwan Advanced Nanotech INC.EchoLUTION Viral RNA/DNA Kit (2 x 48) — BioEcho Life Sciences GmbHNX-Duo Universal DNA Kit A DUE961 — GENOLUTION. INC.BioTeke — Bioteke Corporation (Wuxi) Co., Ltd.BIOER MagaBio plus Virus DNA/RNA Purification Kit II — Hangzhou Bioer Technology Co., Ltd.TANBead Nucleic Acid Extraction Kit — Taiwan Advanced Nanotech INC.cobas® cfDNA Sample Preparation Kit — Roche Molecular Systems, Inc.Nucleic Acid Extraction-Purification Kit 3.0 — Sansure Biotech Inc.TANBead Nucleic Acid Extraction Kit — Taiwan Advanced Nanotech INC.PCRopsis — ENTOPSIS, LLCAlpha-Tec Systems — Alpha-TEC Systems, Inc.Vivaspin Turbo 15 — SARTORIUS STEDIM LAB LIMITEDTANBead Nucleic Acid Extraction Kit — Taiwan Advanced Nanotech INC.TANBead Nucleic Acid Extraction Kit — Taiwan Advanced Nanotech INC.Nucleic Acid Extractor — HANWOOLTPC Co., Ltd.Macro & Micro-Test Viral DNA/RNA Kit — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.Vivapore 10/20 — SARTORIUS STEDIM LAB LIMITEDBIOER GenePure Pro Nucleic Acid Purification System — Hangzhou Bioer Technology Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-06-03 | Qiagen Sciences LLC | Heater shaker module does not perform heating if the temperature is set below 40C for static incubation steps when running IVD protocol QIAamp DSP DNA Mini Kit |
| 2024-03-04 | Qiagen Sciences LLC | Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may st |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2022-11-02 | Qvella Corporation | Device exceeds the limitations of a Class I 510(k)-exempt device so the user manual, instructions for use, and promotional materials are being corrected to remo |
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