OxyPRAS Plus BBE/KVL Bi-Plate

FDA UDI

Class I (US FDA UDI)

by Oxyrase, Inc.

Identity

Trade Name: OxyPRAS Plus BBE/KVL Bi-Plate FDA UDI
Generic Name: Multiple formulation agar culture medium IVD FDA UDI
Device Name: Culture Media, Selective and Non-Differential FDA UDI
Model / Reference: B-BCD-KV FDA UDI
Description: Culture Media, Selective and Non-Differential FDA UDI

Identifiers

Catalog Number: B-BCD-KV FDA UDI
Primary DI / UDI-DI: 00850056467025 FDA UDI
FDA Product Code: JSJ FDA UDI
GMDN Term: Multiple formulation agar culture medium IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.2360 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Weight — 24 Gram FDA UDI

Category: Multiple formulation agar culture medium IVD

OxyPRAS Plus BBE/KVL Bi-Plate by Oxyrase, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Oxyrase, Inc.

Sources (1)

FDA UDI d2882a6a-6ebc-4d03-993d-1089052ab0e3 37 fields · synced May 30, 2026