Coatest APCR Control Plasma Level 1

FDA UDI

Class II (US FDA UDI)

by Instrumentation Laboratory Company

Identity

Trade Name: Coatest APCR Control Plasma Level 1 FDA UDI
Generic Name: Multiple coagulation factor IVD, control FDA UDI
Device Name: Coatest APCR Control Plasma Level 1 FDA UDI
Model / Reference: 82 2650 63 FDA UDI
Description: Coatest APCR Control Plasma Level 1 FDA UDI

Identifiers

Catalog Number: 82 2650 63 FDA UDI
Primary DI / UDI-DI: 08426950088912 FDA UDI
510(k) Number: K945940 FDA UDI
FDA Product Code: GGW FDA UDI
GMDN Term: Multiple coagulation factor IVD, control 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple coagulation factor IVD, control

Coatest APCR Control Plasma Level 1 by Instrumentation Laboratory Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
CRYOcheck™ Abnormal 1 Reference Control — Precision Biologic · Class II
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CueSee® Coag — Eurotrol B.V. · Class II
COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1) — Randox Laboratories, Ltd. · Class I

Cleared under the same submission

K945940 also covers:

Coatest APCR Control Plasma Level 2 — INSTRUMENTATION LABORATORY COMPANY

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	Class II	Pending data

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Manufacturer

Manufacturer: Instrumentation Laboratory Company

Sources (1)

FDA UDI 17a3b13e-1d9a-4b88-b345-33c3d8a49fd4 37 fields · synced May 30, 2026