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Device Explorer · FDA GUDID · GMDN 60736

Nucleic acid sample preparation instrument IVD

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the automated pre-analytical preparation of samples for downstream nucleic acid analysis. The instrument may be used to prepare various sample types through one o

US‑registered devices92in commercial distribution
Companies20labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription26%Rx‑only share
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Share of device records

Hangzhou Allsheng Instruments Co.,Ltd.1213%
Taiwan Advanced Nanotech Inc.1213%
Kh Medical Co., Ltd.1112%
Hangzhou Bioer Technology Co., Ltd.910%
Biobase Biodustry(Shandong)Co., Ltd.910%
Jiangsu Bioperfectus Technologies Co., Ltd.55%
Life Technologies Holdings Pte. Ltd.55%
Sansure Biotech Inc.44%

Top labelers

CompanyDevicesShare
Hangzhou Allsheng Instruments Co.,Ltd.1213%
Taiwan Advanced Nanotech Inc.1213%
Kh Medical Co., Ltd.1112%
Hangzhou Bioer Technology Co., Ltd.910%
Biobase Biodustry(Shandong)Co., Ltd.910%
Jiangsu Bioperfectus Technologies Co., Ltd.55%
Life Technologies Holdings Pte. Ltd.55%
Sansure Biotech Inc.44%
Biomerieux Sa44%
Bioneer Corporation44%
Bioteke Corporation (Wuxi) Co., Ltd.33%
Qiagen Gmbh33%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ALLSHENGBioTekeGenePure Pro 16H Nucleic Acid Purification SysteSimplicity TM Dx Extraction SystemBIOER Automated Nucleic Acid Purification SystemBIOER GenePure 96 Nucleic Acid Purification SystBIOER GenePure Pro Nucleic Acid Purification SysAutomated Nucleic Acids Extraction System ANDiS ReadiMag FFPE DNA/RNA KitAutomated Nucleic Acid Extraction WorkstationNucleic Acid Extraction SystemNATCH S-F11C SystemNATCH S-F11B SystemX-Lysa Solo SystemX-Lysa Flex SystemBIOBASE

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
JJHClinical Sample Concentrator80
JJHClinical sample concentrator6
JJHCLINICAL SAMPLE CONCENTRATOR5
JQWStation, Pipetting And Diluting, For Clinical Use2
QBHLower respiratory microbial nucleic acid detection system1
MKTHepatitis Viral B DNA Detection 1

GMDN & GCC registration

  • GMDN code 60736 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 26% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Kilogram) · 1

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How many nucleic acid sample preparation instrument ivd products are registered in the US?

92 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Nucleic acid sample preparation instrument IVD", from 20 companies. The largest labeler is Hangzhou Allsheng Instruments Co.,Ltd. with 13% of records.

Which FDA product codes apply?

JJH (Clinical Sample Concentrator), JJH (Clinical sample concentrator), JJH (CLINICAL SAMPLE CONCENTRATOR), JQW (Station, Pipetting And Diluting, For Clinical Use)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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