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Vitek® 2 Ast-St01

FDA UDI

Class II (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
VITEK® 2 AST-ST01 FDA UDI
Generic Name
General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
Device Name
The VITEK ® 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of S. pneumo , beta-hemolytic Strep, & Viridans Strep FDA UDI
Model / Reference
VITEK®2 AST-ST01 FDA UDI
Description
The VITEK ® 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of S. pneumo , beta-hemolytic Strep, & Viridans Strep FDA UDI

Identifiers

Primary DI / UDI-DI
03573026529741 FDA UDI
510(k) Number
K111599 FDA UDI
K111893 FDA UDI
K111909 FDA UDI
K111976 FDA UDI
K112000 FDA UDI
K112075 FDA UDI
K112129 FDA UDI
K112228 FDA UDI
K113305 FDA UDI
K121100 FDA UDI
K121863 FDA UDI
K122359 FDA UDI
FDA Product Code
LON FDA UDI
GMDN Term
General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.1645 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Vitek® 2 Ast-St01 by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K111599 also covers:

K111893 also covers:

K111909 also covers:

K111976 also covers:

K112000 also covers:

K112075 also covers:

K112129 also covers:

K112228 also covers:

K121100 also covers:

K121863 also covers:

K122359 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomerieux , Inc.

Sources (1)

  • FDA UDI d68e1a47-9406-4ce3-9403-618d144b9f24 36 fields · synced May 30, 2026