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L. pneu 1-6/bdglmj DFA Screen

FDA UDI

Class II (US FDA UDI)

by Scimedx Corp.

Identity

Trade Name
L. pneu 1-6/bdglmj DFA Screen FDA UDI
Generic Name
Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay FDA UDI
Model / Reference
700SC FDA UDI

Identifiers

Catalog Number
700SC FDA UDI
Primary DI / UDI-DI
00813545023256 FDA UDI
510(k) Number
K822066 FDA UDI
FDA Product Code
LHL FDA UDI
GMDN Term
Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3300 FDA UDI
Commercial Distribution
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

No

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: Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay

L. pneu 1-6/bdglmj DFA Screen by Scimedx Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay.

Cleared under the same submission

K822066 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scimedx Corp.

Sources (1)

  • FDA UDI ccce72cf-a5b0-49ef-a7d7-4d2206595b18 35 fields · synced May 30, 2026