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George King Positive Lupus Anticoagulant

FDA UDI

Class II (US FDA UDI)

by George King Bio-Medical, Inc.

Identity

Trade Name
George King Positive Lupus Anticoagulant FDA UDI
Generic Name
Lupus anticoagulant marker IVD, control FDA UDI
Device Name
George King Positive Lupus Anticoagulant is citrated human fresh frozen plasma derived from donors who have been diagnosed with the Anti-Phospholipid Antibody Syndrome. (APS) FDA UDI
Model / Reference
5000-1.5 FDA UDI
Description
George King Positive Lupus Anticoagulant is citrated human fresh frozen plasma derived from donors who have been diagnosed with the Anti-Phospholipid Antibody Syndrome. (APS) FDA UDI

Identifiers

Primary DI / UDI-DI
00815696020450 FDA UDI
510(k) Number
K945856 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

George King Positive Lupus Anticoagulant by George King Bio-Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K945856 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
George King Bio-Medical, Inc.

Sources (1)

  • FDA UDI 82b1770e-1739-432c-94e3-52bf466df1e1 36 fields · synced Jun 8, 2026