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Vitek® 2 Ast-Gp68

FDA UDI

Class II (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
VITEK® 2 AST-GP68 FDA UDI
Generic Name
General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
Device Name
VITEK ® 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 to determine susceptibility of Staphylococcus spp., Enterococcus spp., & S. agalactiae FDA UDI
Model / Reference
VITEK® 2 AST-GP68 FDA UDI
Description
VITEK ® 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 to determine susceptibility of Staphylococcus spp., Enterococcus spp., & S. agalactiae FDA UDI

Identifiers

Primary DI / UDI-DI
03573026530792 FDA UDI
510(k) Number
K020871 FDA UDI
K031410 FDA UDI
K031865 FDA UDI
K051849 FDA UDI
K053186 FDA UDI
K063597 FDA UDI
K063623 FDA UDI
K083383 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
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

Category: General-microorganism antimicrobial susceptibility culture medium IVD

Vitek® 2 Ast-Gp68 by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-microorganism antimicrobial susceptibility culture medium IVD.

Cleared under the same submission

K020871 also covers:

K031410 also covers:

K031865 also covers:

K051849 also covers:

K053186 also covers:

K063597 also covers:

K063623 also covers:

K083383 also covers:

N50510 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 7e1db16f-a010-4696-96b0-6bf7dfcee545 35 fields · synced May 30, 2026