Qstat Control Level 1

FDA UDI

by Hemosonics LLC

Identity

Trade Name: Qstat Control Level 1 FDA UDI
Generic Name: Coagulation analyser IVD, laboratory FDA UDI
Device Name: For Use with the QUANTRA® Hemostasis Analyzer FDA UDI
Model / Reference: QStat Control Level 1 Kit (Box of 4) FDA UDI
Description: For Use with the QUANTRA® Hemostasis Analyzer FDA UDI

Identifiers

Primary DI / UDI-DI: 00850003761336 FDA UDI
510(k) Number: K213917 FDA UDI
GMDN Term: Coagulation analyser IVD, laboratory FDA UDI

Classification

Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

Yes

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Coagulation analyser IVD, laboratory

Qstat Control Level 1 by Hemosonics LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K213917 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	N/A	Pending data

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Manufacturer

Manufacturer: Hemosonics LLC

Sources (1)

FDA UDI ddfb91f4-a23c-4113-8209-48392d3ceea3 36 fields · synced Jun 7, 2026