Identity
- Trade Name
- Formalin / C&S / Clean Stool Collection Kits FDA UDI
- Generic Name
- 10% Neutral buffered formalin IVD FDA UDI
- Device Name
- Convenience kit containing Formalin, C&S and Clean Vials for stool collection. FDA UDI
- Model / Reference
- 891-20 FDA UDI
- Description
- Convenience kit containing Formalin, C&S and Clean Vials for stool collection. FDA UDI
Identifiers
- Catalog Number
- 891-20 FDA UDI
- Primary DI / UDI-DI
- M445891201 FDA UDI
- FDA Product Code
- IFP FDA UDIJSM FDA UDINNI FDA UDI
- GMDN Term
- 10% Neutral buffered formalin IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 FDA UDI866.2390 FDA UDI864.3250 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General specimen receptacle transport containerCarey-Blair transport medium IVD10% Neutral buffered formalin IVD
Formalin / C&S / Clean Stool Collection Kits by Medical Chemical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as 10% Neutral buffered formalin IVD.
- Rowley Biochemical Neutral Buffered Formalin — Transene Company, Inc. · Class I
- Tissue-Tek® — Sakura Finetek USA, Inc · Class I
- Tissue-Tek ClearFIX® — Sakura Finetek USA, Inc · Class I
- O&P Collection Vials Zinc PVA / Formalin / C&S Kits — Medical Chemical Corporation · Class I
- O&P Collection Vials Formalin/C&S Kits — Medical Chemical Corporation · Class I
- Z-PVA / Formalin / C&S / Clean O&P Collection Kits — Medical Chemical Corporation · Class I
- Total-Fix / Formalin / C&S / Clean O&P Collection Kits — Medical Chemical Corporation · 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
- Medical Chemical Corporation
Sources (1)
- FDA UDI ee97ea59-6cde-4287-8592-798ec31d1be9 35 fields · synced Jun 9, 2026