CRYOcheck™ Reference Control Normal

FDA UDI

Class II (US FDA UDI)

by Precision Biologic

Identity

Trade Name: CRYOcheck™ Reference Control Normal FDA UDI
Generic Name: Multiple coagulation factor IVD, control FDA UDI
Model / Reference: RCN-05 FDA UDI

Identifiers

Primary DI / UDI-DI: 00843876000053 FDA UDI
510(k) Number: K013708 FDA UDI
FDA Product Code: GIZ FDA UDI
GMDN Term: Multiple coagulation factor 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

CRYOcheck™ Reference Control Normal by Precision Biologic — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple coagulation factor IVD, control.

directCHECK Whole Blood Controls — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
Coagulation S.A.R.P (Specialty Assayed Reference Plasma) — Helena Laboratories, Corp. · Class II
Dade Ci-Trol Coagulation Control Level 1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
JAS Diagnostics — Drew Scientific , Ltd.
CueSee® Coag — Eurotrol B.V. · Class II
COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1) — Randox Laboratories, Ltd. · Class I
IDG/Sanzay — IDG/SANZAY Corporation · Class II

Cleared under the same submission

K013708 also covers:

CRYOcheck™ Reference Control Normal — Precision Biologic

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: Precision Biologic

Sources (1)

FDA UDI 2021a85c-9b4d-46f6-a348-4d689b42daea 33 fields · synced Jun 6, 2026