Home › Device types › JJH
Clinical Sample Concentrator
FDA product code JJH · Class 1 · Clinical Chemistry
629
Registered devices
294
Adverse events
31
Recalls
15
510(k) clearances
Devices with this code
NX Genomic DNA Kit A NGD321 — GENOLUTION. INC.EchoLUTION Viral RNA/DNA Kit (16 x 96) — BioEcho Life Sciences GmbHNucleic Acid Extraction and Purification Kit 2.0 — Sansure Biotech Inc.Vivaspin Filtrate — SARTORIUS STEDIM LAB LIMITEDMawi DNA Technologies — Mawi Dna Technologies, LLCBIOER MagaBio plus Virus DNA/RNA Purification Kit II — Hangzhou Bioer Technology Co., Ltd.TANBead Nucleic Acid Extraction Kit — Taiwan Advanced Nanotech INC.Viral Nucleic Acid Extraction Kit (Magnetic Bead Method) — Jiangsu Bioperfectus Technologies Co., Ltd.Vivaspin 20 — SARTORIUS STEDIM LAB LIMITEDQIAsymphony® DSP Circulating DNA Kit — QIAGEN GmbHNX-Duo Genomic DNA Kit B DGD241 — GENOLUTION. INC.TANBead Nucleic Acid Extraction Kit — Taiwan Advanced Nanotech INC.m2000 — ABBOTT MOLECULAR INC.PCRopsis — ENTOPSIS, LLCTANBead Nucleic Acid Extraction Kit — Taiwan Advanced Nanotech INC.BIOER GenePure 96 Nucleic Acid Purification System — Hangzhou Bioer Technology Co., Ltd.ViroKey™ SX Virus Total Nucleic Acid Kit — VELA OPERATIONS SINGAPORE PTE. LTD.chemagic 360-D — Wallac OyVivafree 500 — SARTORIUS STEDIM LAB LIMITEDVivapore 5 — SARTORIUS STEDIM LAB LIMITEDNucleic Acid Extraction Rapid Kit (Magnetic Bead Method) — Jiangsu Bioperfectus Technologies Co., Ltd.32B Automated Viral RNA Isolation Kit — 3D Biomedicine Science & Technology Co., LimitedXCELL — APEX BIOLOGIX , LLCNucleic Acid Extraction-Purification Kit 4.0 — Sansure Biotech Inc.
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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