Z-PVA / Formalin / C&S / Clean O&P Collection Kits

FDA UDI

Class I (US FDA UDI)

by Medical Chemical Corporation

Identity

Trade Name: Z-PVA / Formalin / C&S / Clean O&P Collection Kits FDA UDI
Generic Name: Carey-Blair transport medium IVD FDA UDI
Device Name: Convenience kit containing Zinc PVA, Formalin, C&S and Clean Vials for stool sample collection. FDA UDI
Model / Reference: 892-03 FDA UDI
Description: Convenience kit containing Zinc PVA, Formalin, C&S and Clean Vials for stool sample collection. FDA UDI

Identifiers

Catalog Number: 892-03 FDA UDI
Primary DI / UDI-DI: M445892031 FDA UDI
FDA Product Code: JSM FDA UDI
LDX FDA UDI
NNI FDA UDI
IFP FDA UDI
GMDN Term: Carey-Blair transport medium IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.2390 FDA UDI
864.4010 FDA UDI
864.3250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: General specimen receptacle transport container Carey-Blair transport medium IVD Fixative, metallic 10% Neutral buffered formalin IVD

Z-PVA / Formalin / C&S / Clean O&P 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
Formalin / C&S / Clean Stool 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 08eb8a34-5355-494e-8b4c-06d738b70a85 35 fields · synced Jun 9, 2026