FDA UDI
In Commercial Distribution
🇺🇸 United States
EXENT® HCCA MALDI Matrix Pack
DI: 05051700020664
·
Model: IK820
·
THE BINDING SITE GROUP LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EXENT® HCCA MALDI Matrix Pack
- Primary DI
- 05051700020664
- Version / Model
- IK820
- Company Name
- THE BINDING SITE GROUP LIMITED
- Labeler DUNS
- 347045614
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-27
- Public Version
- 1
- Public Version Date
- 2025-12-05
- Public Version Status
- New
- Public Device Record Key
- d560a158-7ff6-464c-9c66-34ed06ff485a
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| OTA | Mass Spectrometer For Clinical Multiplex Test Systems | Clinical Chemistry | 862.2570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61336 | Mass spectrometry analysis specimen preparation kit IVD | A collection of reagents and other associated materials intended to be used in the preparation of a previously processed clinical specimen (e.g., nucleic acids, proteins) for mass spectrometry analysis (e.g., electrospray ionization, MALDI-TOF). It typically consists of organic/inorganic compound solutions (e.g., imidazole, ammonium bicarbonate) that may added to a volatile solution (e.g., methanol, acetonitrile, hexane) to enable the specimen to disperse into a fine aerosol, and/or promote ionisation of the analyte. The kit can be used with manual or automated instruments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05051700020664 | GS1 |
Customer Contacts
- Phone
- +441214569500
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius