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ImmunoDOT Borrelia Positive Control

FDA UDI

Class II (US FDA UDI)

by Genbio

Identity

Trade Name
ImmunoDOT Borrelia Positive Control FDA UDI
Generic Name
Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, control FDA UDI
Device Name
This serum control contains IgG antibodies specific to Borrelia burgdorferi, the causative agent of Lyme Disease, and is to be used in conjunction with the appropriate ImmunoDOT Assay Test System. FDA UDI
Model / Reference
800-3905 FDA UDI
Description
This serum control contains IgG antibodies specific to Borrelia burgdorferi, the causative agent of Lyme Disease, and is to be used in conjunction with the appropriate ImmunoDOT Assay Test System. FDA UDI

Identifiers

Catalog Number
3905 FDA UDI
Primary DI / UDI-DI
00613745039053 FDA UDI
510(k) Number
K911590 FDA UDI
FDA Product Code
LSR FDA UDI
GMDN Term
Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3830 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

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

ImmunoDOT Borrelia Positive Control by Genbio — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K911590 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Genbio

Sources (1)

  • FDA UDI 4b65fffe-3877-45e8-a45a-be61daa38160 39 fields · synced May 30, 2026