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Coatest APC Resistance V-S

FDA UDI

Class II (US FDA UDI)

by Instrumentation Laboratory Company

Identity

Trade Name
Coatest APC Resistance V-S FDA UDI
Generic Name
Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting FDA UDI
Device Name
Coatest APC Resistance V-S FDA UDI
Model / Reference
82 3138 63 FDA UDI
Description
Coatest APC Resistance V-S FDA UDI

Identifiers

Catalog Number
82 3138 63 FDA UDI
Primary DI / UDI-DI
08426950076100 FDA UDI
510(k) Number
K963111 FDA UDI
FDA Product Code
GGW FDA UDI
GMDN Term
Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7925 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting

Coatest APC Resistance V-S by Instrumentation Laboratory Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Activated protein C resistant factor V (factor V Leiden) IVD, kit, clotting.

Cleared under the same submission

K963111 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Instrumentation Laboratory Company

Sources (1)

  • FDA UDI 6390820a-3ffa-4bac-b02d-8a8de5f4dce5 37 fields · synced May 30, 2026