FDA UDI
In Commercial Distribution
🇺🇸 United States
Reagent
DI: 04250317536624
·
Model: 80002
·
Chromsystems Instruments + Chemicals GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Reagent
- Primary DI
- 04250317536624
- Version / Model
- 80002
- Catalog Number
- 80002
- 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
- 14118d66-9b79-4d6d-a084-6fe76859b6d5
Device Description
Mobile Phase B, MassChrom® Biogenic Amines/Metabolites in urine, Chromatographic Platform
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 |
|---|---|---|---|---|
| 63824 | Multiple biogenic amine neurotransmitter IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250317536624 | GS1 |
Customer Contacts
- Phone
- +4989189300
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 500 ml |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 30 Degrees Celsius