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Mast Assure

FDA UDI

Class II (US FDA UDI)

by Mast Group , Ltd.

Identity

Trade Name
Mast Assure FDA UDI
Generic Name
Shigella boydii culture isolate antigen IVD, kit, agglutination FDA UDI
Device Name
M10113 - Shigella boydii Polyvalent Typing Antiserum - POLY C1 Types 8, 9, 10, 11 - 2ml FDA UDI
Model / Reference
M10113 FDA UDI
Description
M10113 - Shigella boydii Polyvalent Typing Antiserum - POLY C1 Types 8, 9, 10, 11 - 2ml FDA UDI

Identifiers

Catalog Number
M10113 FDA UDI
Primary DI / UDI-DI
15060392376468 FDA UDI
FDA Product Code
GNB FDA UDI
GMDN Term
Shigella boydii culture isolate antigen IVD, kit, agglutination FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Shigella boydii culture isolate antigen IVD, kit, agglutination

Mast Assure by Mast Group , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Shigella boydii culture isolate antigen IVD, kit, agglutination.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mast Group , Ltd.

Sources (1)

  • FDA UDI 15233bbd-f305-44a6-a6cf-2916d972f80a 35 fields · synced Jun 8, 2026