FDA UDI
In Commercial Distribution
🇺🇸 United States
STARMag M96 Kit
DI: 08809240000281
·
Model: 1
·
SEEGENE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- STARMag M96 Kit
- Primary DI
- 08809240000281
- Version / Model
- 1
- Catalog Number
- EX00029P
- Company Name
- SEEGENE, INC.
- Labeler DUNS
- 688370667
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-28
- Public Version
- 3
- Public Version Date
- 2025-12-08
- Public Version Status
- Update
- Public Device Record Key
- ae70e94e-2ab5-45e9-8d12-805a48f6cf09
Device Description
for isolation of nucleic acid from nasopharyngeal swab, oropharyngeal(throat) swab, saliva, sputum, urine, stool, rectal swab, fecal swab, semen, genital swabs (vaginal, cervical, urethral), liquid based cytology (LBC), whole blood and cerebrospinal fluid (CSF) specimen using automated liquid handling instrument
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJH | Clinical Sample Concentrator | Clinical Chemistry | 862.2310 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52521 | Nucleic acid extraction/isolation kit IVD | A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809240000281 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius