Identity
- Trade Name
- Atellica CH Cholinesterase_2 FDA UDI
- Generic Name
- Pseudocholinesterase IVD, kit, spectrophotometry FDA UDI
- Device Name
- Cholinestrase (CHE_2) Atellica CH FDA UDI
- Model / Reference
- 11537221 FDA UDI
- Description
- Cholinestrase (CHE_2) Atellica CH FDA UDI
Identifiers
- Catalog Number
- 11537221 FDA UDI
- Primary DI / UDI-DI
- 00630414611044 FDA UDI
- FDA Product Code
- DIH FDA UDI
- GMDN Term
- Pseudocholinesterase IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3240 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: Pseudocholinesterase IVD, kit, spectrophotometry
Atellica CH Cholinesterase_2 by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pseudocholinesterase IVD, kit, spectrophotometry.
- BUTYRYL CHOLINESTERASE (CHE) — Randox Laboratories, Ltd. · Class I
- BUTYRYL CHOLINESTERASE (CHE) — Randox Laboratories, Ltd. · Class I
- PChE Assay Kit — Eqm Research, Inc. · Class I
- Dimension® Flex® reagent cartridge PCHE — Siemens Healthcare Diagnostics · Class I
- Dimension Vista® Flex® reagent cartridge PCHE — Siemens Healthcare Diagnostics · 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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI ec71aea0-136b-4bdd-9f33-c6288300eefa 36 fields · synced Jun 6, 2026