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QuikCoag Control Level 1 Normal

FDA UDI

Class II (US FDA UDI)

by Biomedica Diagnostics Inc

Identity

Trade Name
QuikCoag Control Level 1 Normal FDA UDI
Generic Name
Activated partial thromboplastin time (APTT) IVD, control FDA UDI
Model / Reference
1 mL FDA UDI

Identifiers

Primary DI / UDI-DI
00627944000066 FDA UDI
510(k) Number
K022046 FDA UDI
FDA Product Code
GGN FDA UDI
GMDN Term
Activated partial thromboplastin time (APTT) IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5425 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

No

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: Prothrombin time (PT) IVD, controlActivated partial thromboplastin time (APTT) IVD, control

QuikCoag Control Level 1 Normal by Biomedica Diagnostics Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Activated partial thromboplastin time (APTT) IVD, control.

Cleared under the same submission

K022046 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomedica Diagnostics Inc

Sources (1)

  • FDA UDI 85fd9c45-2796-4f26-9da3-59fb647c876b 34 fields · synced May 30, 2026