FDA UDI
In Commercial Distribution
🇺🇸 United States
Reagent Kit
DI: 04250317540065
·
Model: 81000/C
·
Chromsystems Instruments + Chemicals GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Reagent Kit
- Primary DI
- 04250317540065
- Version / Model
- 81000/C
- Catalog Number
- 81000/C
- Company Name
- Chromsystems Instruments + Chemicals GmbH
- Labeler DUNS
- 328712260
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-27
- Public Version
- 1
- Public Version Date
- 2020-09-04
- Public Version Status
- New
- Public Device Record Key
- 7db13c83-44ca-415f-a255-a59352cc1e9d
Device Description
LC-MS/MS Reagent Kit, including Sample Clean Up Columns, MassChrom® Free Metanephrines in plasma
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
- 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 |
|---|---|---|---|---|
| CHQ | Chromatographic/Fluorometric Method, Catecholamines | Clinical Chemistry | 862.1165 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63892 | Multiple biogenic amine neurotransmitter IVD, kit, liquid chromatography/mass spectrometry (LC/MS) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple biogenic amine neurotransmitters [e.g., catecholamines (dopamine, norepinephrine, epinephrine), histamine, serotonin] and/or multiple biogenic amine neurotransmitter intermediate metabolites (e.g., metanephrine, normetanephrine, 3-methoxytyramine) in a clinical specimen, using a liquid chromatography/mass spectrometry (LC/MS) method. It is typically used as an aid in the diagnosis of catecholamine-secreting tumours (e.g., pheochromocytoma). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250317540065 | GS1 |
Customer Contacts
- Phone
- +4989189300
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2 x 96 analyses |