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Immco Diagnostics

FDA UDI

Class II (US FDA UDI)

by Immco Diagnostics, Inc.

Identity

Trade Name
IMMCO DIAGNOSTICS FDA UDI
Generic Name
Buffered sample diluent IVD, manual FDA UDI
Device Name
Serum Diluent FDA UDI
Model / Reference
5308 FDA UDI
Description
Serum Diluent FDA UDI

Identifiers

Catalog Number
5308 FDA UDI
Primary DI / UDI-DI
00845714002960 FDA UDI
FDA Product Code
MOB FDA UDI
MST FDA UDI
MVM FDA UDI
DHR FDA UDI
LLL FDA UDI
LRM FDA UDI
GMDN Term
Buffered sample diluent IVD, manual FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5660 FDA UDI
866.5750 FDA UDI
866.5775 FDA UDI
866.5100 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

Yes

FDA UDI

Category: Buffered sample diluent IVD, manual

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

Similar devices

Also classified as Buffered sample diluent IVD, manual.

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 0ecd3c21-cbf6-4e2f-925a-3c2620ae96e8 37 fields · synced Sep 17, 2026