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Borrelia IgM Control

FDA UDI

Class II (US FDA UDI)

by Bion Enterprises, Ltd.

Identity

Trade Name
Borrelia IgM Control FDA UDI
Generic Name
Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, control FDA UDI
Model / Reference
BBM-6130 FDA UDI

Identifiers

Catalog Number
BBM-6130 FDA UDI
Primary DI / UDI-DI
B110BBM61300 FDA UDI
510(k) Number
K901054 FDA UDI
FDA Product Code
LSR FDA UDI
GMDN Term
Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3830 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Category: Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, control

Borrelia IgM Control by Bion Enterprises, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, control.

Cleared under the same submission

K901054 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bion Enterprises, Ltd.

Sources (1)

  • FDA UDI 52631817-88b3-43aa-a430-7cb9f2f0fbcd 35 fields · synced May 30, 2026