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ASTar BC G- Kit software

FDA UDI

Class II (US FDA UDI)

by Q-Linea AB

Identity

Trade Name
ASTar BC G- Kit software FDA UDI
Generic Name
Multiple-type pathogen antimicrobial susceptibility testing kit IVD FDA UDI
Device Name
Antimicrobial Susceptibility Testing - Gram negative FDA UDI
Model / Reference
50005827 FDA UDI
Description
Antimicrobial Susceptibility Testing - Gram negative FDA UDI

Identifiers

Primary DI / UDI-DI
07350136800054 FDA UDI
510(k) Number
K221688 FDA UDI
FDA Product Code
SAN FDA UDI
LON FDA UDI
GMDN Term
Multiple-type pathogen antimicrobial susceptibility testing kit IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.1650 FDA UDI
866.1645 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple-type pathogen antimicrobial susceptibility testing kit IVD

ASTar BC G- Kit software by Q-Linea AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-type pathogen antimicrobial susceptibility testing kit IVD.

Cleared under the same submission

K221688 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Q-Linea AB

Sources (1)

  • FDA UDI f7b6c337-7223-4a06-85a3-9d132030d58a 35 fields · synced Jun 1, 2026