CRYOcheck™ Weak Lupus Positive Control

FDA UDI

Class II (US FDA UDI)

by Precision Biologic

Identity

Trade Name: CRYOcheck™ Weak Lupus Positive Control FDA UDI
Generic Name: Lupus anticoagulant marker IVD, control FDA UDI
Model / Reference: CCWLP-05 FDA UDI

Identifiers

Primary DI / UDI-DI: 00843876000169 FDA UDI
510(k) Number: K032804 FDA UDI
FDA Product Code: GGC FDA UDI
GMDN Term: Lupus anticoagulant marker 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: Lupus anticoagulant marker IVD, control

CRYOcheck™ Weak Lupus Positive Control by Precision Biologic — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lupus anticoagulant marker IVD, control.

LA Control Low — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
George King Positive Lupus Anticoagulant — GEORGE KING BIO-MEDICAL, INC. · Class II
LAtrol ABNORMAL CONTROL PLASMA — Biomedica ADI Inc. · Class II
George King Positive Lupus Anticoagulant — GEORGE KING BIO-MEDICAL, INC. · Class II
LA Control High — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
LAtrol NORMAL CONTROL PLASMA — Biomedica ADI Inc. · Class II
LA Control High — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
George King Positive Lupus Anticoagulant — GEORGE KING BIO-MEDICAL, INC. · Class II

Cleared under the same submission

K032804 also covers:

CRYOcheck™ Weak Lupus Positive Control — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Precision Biologic

Sources (1)

FDA UDI 427dff52-abc6-4d4f-af4a-abc512799812 33 fields · synced May 30, 2026