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Colorzyme® nDNA Test System

FDA UDI

by Immuno Concepts Inc

Identity

Trade Name
Colorzyme® nDNA Test System FDA UDI
Generic Name
Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Custom - nDNA Colorzyme® Bulk Pack - 1400 Wells FDA UDI
Model / Reference
8011 FDA UDI
Description
Custom - nDNA Colorzyme® Bulk Pack - 1400 Wells FDA UDI

Identifiers

Catalog Number
8011 FDA UDI
Primary DI / UDI-DI
M7490080111 FDA UDI
GMDN Term
Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

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

Yes

FDA UDI

Category: Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA)

Colorzyme® nDNA Test System by Immuno Concepts Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Immuno Concepts Inc

Sources (1)

  • FDA UDI 6cb8dafa-b103-4d71-bbfc-d38e01de000d 34 fields · synced May 30, 2026