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Vitek® 2 Ast-Gp67

FDA UDI

Class II (US FDA UDI)

by Biomerieux , Inc.

Identity

Trade Name
VITEK® 2 AST-GP67 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 the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae FDA UDI
Model / Reference
VITEK® 2 AST-GP67 FDA UDI
Description
VITEK ® 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae FDA UDI

Identifiers

Primary DI / UDI-DI
03573026530648 FDA UDI
510(k) Number
K032399 FDA UDI
K032738 FDA UDI
K032766 FDA UDI
K050976 FDA UDI
K053097 FDA UDI
K072668 FDA UDI
K072695 FDA UDI
K080201 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-Gp67 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

K032399 also covers:

K032738 also covers:

K032766 also covers:

K050976 also covers:

K053097 also covers:

K072668 also covers:

K072695 also covers:

K080201 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 13c9f42c-79f0-4dce-9555-7232d0436c53 35 fields · synced May 30, 2026