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Anti-nDNA IgG IFA 96 Test

FDA UDI

Class II (US FDA UDI)

by Hemagen Diagnostics, Inc.

Identity

Trade Name
Anti-nDNA IgG IFA 96 Test FDA UDI
Generic Name
Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay FDA UDI
Device Name
For the detection and titration of anti-native DNA antibodies in human sera FDA UDI
Model / Reference
902420 FDA UDI
Description
For the detection and titration of anti-native DNA antibodies in human sera FDA UDI

Identifiers

Primary DI / UDI-DI
G5229024201 FDA UDI
510(k) Number
K771376 FDA UDI
FDA Product Code
DHN FDA UDI
GMDN Term
Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5100 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: Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay

Anti-nDNA IgG IFA 96 Test by Hemagen Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hemagen Diagnostics, Inc.

Sources (1)

  • FDA UDI 0cccf20e-b08a-4b33-a942-f4347b14c9f1 36 fields · synced May 30, 2026