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Immco Diagnostics, Inc.

FDA UDI

Class II (US FDA UDI)

by Immco Diagnostics, Inc.

Identity

Trade Name
Immco Diagnostics, Inc. FDA UDI
Generic Name
Multiple clinical chemistry protein IVD, kit, immunoblot FDA UDI
Device Name
Lyme B. burgdorferi (IgM) Marstripe Test FDA UDI
Model / Reference
6101M-50 FDA UDI
Description
Lyme B. burgdorferi (IgM) Marstripe Test FDA UDI

Identifiers

Catalog Number
6101M-50 FDA UDI
Primary DI / UDI-DI
00845714004810 FDA UDI
510(k) Number
K172254 FDA UDI
FDA Product Code
LSR FDA UDI
GMDN Term
Multiple clinical chemistry protein IVD, kit, immunoblot 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

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: Multiple clinical chemistry protein IVD, kit, immunoblot

Immco Diagnostics, Inc. by Immco Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry protein IVD, kit, immunoblot.

Cleared under the same submission

K172254 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Immco Diagnostics, Inc.

Sources (1)

  • FDA UDI 95594aeb-7dbc-4f85-b938-5bc0b5342ff5 38 fields · synced Sep 17, 2026