Identity
- Trade Name
- AChE Assay Kit FDA UDI
- Generic Name
- Acetylcholinesterase IVD, kit, spectrophotometry FDA UDI
- Device Name
- For the quantitative determination of Erythrocyte Cholinesterase in whole blood to monitor pesticide exposure. For in vitro diagnostic use. For laboratory use by trained laboratory technicians only. For use only with the Test-mate ChE Cholinesterase Test System (Model 400). Contains materials for 96 tests. FDA UDI
- Model / Reference
- 460 FDA UDI
- Description
- For the quantitative determination of Erythrocyte Cholinesterase in whole blood to monitor pesticide exposure. For in vitro diagnostic use. For laboratory use by trained laboratory technicians only. For use only with the Test-mate ChE Cholinesterase Test System (Model 400). Contains materials for 96 tests. FDA UDI
Identifiers
- Catalog Number
- 460 FDA UDI
- Primary DI / UDI-DI
- 00860010612217 FDA UDI
- 510(k) Number
- K961656 FDA UDI
- FDA Product Code
- DIH FDA UDI
- GMDN Term
- Acetylcholinesterase 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Acetylcholinesterase IVD, kit, spectrophotometry
AChE Assay Kit by Eqm Research, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acetylcholinesterase IVD, kit, spectrophotometry.
- ADVIA® Chemistry CHE Cholinesterase Reagents — Siemens Healthcare Diagnostics · Class I
- Cholinesterase — Roche Diagnostics Corp. · Class I
- ADVIA® Chemistry CHE Cholinesterase Reagents — Siemens Healthcare Diagnostics · Class I
- Cholinesterase Gen.2 — Roche Diagnostics Corp. · Class I
- Test-mate ChE Cholinesterase Test System — Eqm Research, Inc. · Class I
Cleared under the same submission
K961656 also covers:
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 |
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Manufacturer
- Manufacturer
- Eqm Research, Inc.
Sources (1)
- FDA UDI 32adb9cf-7f73-45f5-92a1-be3f29ed33cf 37 fields · synced Jun 8, 2026