Identity
- Trade Name
- PARA-SED FDA UDI
- Generic Name
- Faecal parasite specimen concentration kit IVD FDA UDI
- Device Name
- PARA-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 and ethyl acetate as an additional reagent. FDA UDI
- Model / Reference
- 695A-EA FDA UDI
- Description
- PARA-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 and ethyl acetate as an additional reagent. FDA UDI
Identifiers
- Catalog Number
- 695A-EA FDA UDI
- Primary DI / UDI-DI
- M445695AEA1 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
Para-Sed by Medical Chemical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Faecal parasite specimen concentration kit IVD.
- Alpha-Tec Systems — Alpha-Tec Systems, Inc. · Class I
- Alpha-Tec Systems — Alpha-Tec Systems, Inc. · Class I
- Caplugs/Evergreen — Caplugs, Inc. · Class I
- Caplugs/Evergreen — Caplugs, Inc. · Class I
- Alpha-Tec Systems — Alpha-Tec Systems, Inc. · Class I
- Alpha-Tec Systems — Alpha-Tec Systems, Inc. · Class I
- Alpha-Tec Systems — Alpha-Tec Systems, Inc. · Class I
- Alpha-Tec Systems — Alpha-Tec Systems, Inc. · Class I
Cleared under the same submission
K941129 also covers:
- MICRO-SED — Medical Chemical Corporation
- 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
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medical Chemical Corporation
Sources (1)
- FDA UDI 6ab1ff91-56d3-48de-9fed-9d96c06fb639 35 fields · synced Jun 9, 2026