Identity
- Trade Name
- MICRO-SED FDA UDI
- Generic Name
- Faecal parasite specimen concentration kit IVD FDA UDI
- Device Name
- MICRO-SED is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. This kit contains 50 sets of single use components. FDA UDI
- Model / Reference
- 694A-EA FDA UDI
- Description
- MICRO-SED is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. This kit contains 50 sets of single use components. FDA UDI
Identifiers
- Catalog Number
- 694A-EA FDA UDI
- Primary DI / UDI-DI
- M445694AEA1 FDA UDI
- 510(k) Number
- K941129 FDA UDI
- FDA Product Code
- LKS FDA UDI
- GMDN Term
- Faecal parasite specimen concentration kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2900 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Faecal parasite specimen concentration kit IVD
Micro-Sed by Medical Chemical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K941129 also covers:
- MICRO-SED — Medical Chemical Corporation
- MICRO-SED — Medical Chemical Corporation
- MICRO-SED — Medical Chemical Corporation
- PARA-SED — Medical Chemical Corporation
- PARA-SED — Medical Chemical Corporation
- PARA-SED — Medical Chemical Corporation
- SED-CONNECT — Medical Chemical Corporation
- SED-CONNECT — Medical Chemical Corporation
- SED-CONNECT — Medical Chemical Corporation
- SED-CONNECT — Medical Chemical Corporation
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
- Medical Chemical Corporation
Sources (1)
- FDA UDI 8af141b7-cbc0-4c22-8ede-16640b8381af 35 fields · synced Jun 9, 2026