FDA UDI
In Commercial Distribution
🇺🇸 United States
IDS-i10
DI: 05060169693968
·
Model: IS-810400
·
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IDS-i10
- Primary DI
- 05060169693968
- Version / Model
- IS-810400
- Company Name
- IMMUNODIAGNOSTIC SYSTEMS LIMITED
- Labeler DUNS
- 494268600
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-27
- Public Version
- 3
- Public Version Date
- 2024-01-15
- Public Version Status
- Update
- Public Device Record Key
- 8a56e9af-dd99-4182-8fb2-bf6f598b3de3
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Clinical Chemistry | 862.2160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56724 | Multichannel immunoassay analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple chemical and/or biological markers in a clinical specimen. The analyser typically includes sample processing, requires analyte specific test kits or reagents, and incorporates multiple channels using two or more immunological methods which may include chromatographic or electrochemical separation, together with enzyme, fluorescent, chemiluminescent, nephelometric, radiometric, electrometric and/or photometric detection systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060169693968 | GS1 |
Customer Contacts
- Phone
- +4401915190660
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K091849 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- The analyser can be stored in its original packaging under the following conditions: • Storage temperature 10-40°C. • Relative humidity 80% non condensing. • Duration 2 months
- Type
- Storage Environment Humidity
- Temperature Range
- – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius