STARMag 96x4 Universal Cartridge Kit
FDA UDIEUDAMEDClass I (US FDA UDI)
by Seegene
Identity
- Trade Name
- STARMag 96 x 4 UniVersal Cartridge Kit EUDAMEDSTARMag 96x4 Universal Cartridge Kit FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- STARMag 96 x 4 UniVersal Cartridge Kit EUDAMEDfor isolation of nucleic acid from tissue, cells, bacteria, serum, plasma, nasopharyngeal swab, nasopharyngeal aspirates, bronchoalveolar lavage (BAL), urine, stool, sputum, whole blood, genital swabs (vaginal, cervical, urethral), liquid based cytology (LBC), cerebrospinal fluid (CSF), semen and saliva specimen using automated liquid handling instrument FDA UDI
- Model / Reference
- 744300.4.UC384 EUDAMED1 FDA UDI
- Description
- for isolation of nucleic acid from tissue, cells, bacteria, serum, plasma, nasopharyngeal swab, nasopharyngeal aspirates, bronchoalveolar lavage (BAL), urine, stool, sputum, whole blood, genital swabs (vaginal, cervical, urethral), liquid based cytology (LBC), cerebrospinal fluid (CSF), semen and saliva specimen using automated liquid handling instrument FDA UDI
Identifiers
- Catalog Number
- 744300.4.UC384 FDA UDI
- Primary DI / UDI-DI
- 08809240000007 EUDAMEDFDA UDI
- Basic UDI-DI
- 9240007443004UC EUDAMED
- FDA Product Code
- JJH FDA UDI
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
- GMDN Term
- Nucleic acid extraction/isolation kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
Yes
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Nucleic acid extraction/isolation kit IVD
STARMag 96x4 Universal Cartridge Kit by Seegene — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Seegene
Sources (2)
- FDA UDI db9679cf-3236-4ee1-b9b4-8da619406e76 35 fields · synced Jul 11, 2026
- EUDAMED 31405200-3f1d-4836-b02a-049c91cb3e12 61 fields · synced Jul 11, 2026