Identity
- Trade Name
- O&P Collection Vials Formalin/C&S Kits FDA UDI
- Generic Name
- 10% Neutral buffered formalin IVD FDA UDI
- Device Name
- Convenience kit containing C&S Vials and Buffered Formalin Vials. FDA UDI
- Model / Reference
- 890-21 FDA UDI
- Description
- Convenience kit containing C&S Vials and Buffered Formalin Vials. FDA UDI
Identifiers
- Catalog Number
- 890-21 FDA UDI
- Primary DI / UDI-DI
- M445890211 FDA UDI
- FDA Product Code
- IFP FDA UDIJSM 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 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: Carey-Blair transport medium IVD10% Neutral buffered formalin IVD
O&P Collection Vials Formalin/C&S 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.
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- O&P Collection Vials Zinc PVA / Formalin / C&S Kits — Medical Chemical Corporation · Class I
- Formalin / C&S / Clean Stool Collection 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 |
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Manufacturer
- Manufacturer
- Medical Chemical Corporation
Sources (1)
- FDA UDI d4bbdcda-23e2-4a59-b971-f518c7faa71e 35 fields · synced Jun 9, 2026