Identity
- Trade Name
- Reagent Kit FDA UDI
- Generic Name
- Multiple biogenic amine neurotransmitter IVD, kit, liquid chromatography/mass spectrometry (LC/MS) FDA UDI
- Device Name
- MassChrom® Biogenic Amines/Metabolites in urine, Sample Prep Set Catecholamines, free Metanephrines, Serotonin including sample clean up columns FDA UDI
- Model / Reference
- 80600/C FDA UDI
- Description
- MassChrom® Biogenic Amines/Metabolites in urine, Sample Prep Set Catecholamines, free Metanephrines, Serotonin including sample clean up columns FDA UDI
Identifiers
- Catalog Number
- 80600/C FDA UDI
- Primary DI / UDI-DI
- 04250317539151 FDA UDI
- FDA Product Code
- CHQ FDA UDI
- GMDN Term
- Multiple biogenic amine neurotransmitter IVD, kit, liquid chromatography/mass spectrometry (LC/MS) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1165 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple biogenic amine neurotransmitter IVD, kit, liquid chromatography/mass spectrometry (LC/MS)
Reagent Kit by Chromsystems Instruments & Chemicals GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple biogenic amine neurotransmitter IVD, kit, liquid chromatography/mass spectrometry (LC/MS).
- Reagent Kit — Chromsystems Instruments & Chemicals GmbH · Class I
- Reagent Kit — Chromsystems Instruments & Chemicals GmbH · Class I
- Reagent Kit — Chromsystems Instruments & Chemicals GmbH · Class I
- Reagent Kit — Chromsystems Instruments & Chemicals GmbH · Class I
- Reagent Kit — Chromsystems Instruments & Chemicals GmbH · Class I
- Reagent Kit — Chromsystems Instruments & Chemicals GmbH · Class I
- Reagent Kit — Chromsystems Instruments & Chemicals GmbH · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Chromsystems Instruments & Chemicals GmbH
Sources (1)
- FDA UDI d177215a-011b-444d-bd39-de4ba21e6ef6 36 fields · synced Jun 8, 2026