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Mlb 2

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Medical Diagnostics GmbH

Identity

Trade Name
MLB 2 FDA UDI
Generic Name
Low ionic-strength salt solution (LISS) immunohaematology reagent IVD FDA UDI
Device Name
Modified LISS-Enhancement media for TANGO® optimo and tube test; 10x10ml FDA UDI
Model / Reference
805205100 FDA UDI
Description
Modified LISS-Enhancement media for TANGO® optimo and tube test; 10x10ml FDA UDI

Identifiers

Catalog Number
805205100 FDA UDI
Primary DI / UDI-DI
07611969950911 FDA UDI
FDA Product Code
KSZ FDA UDI
GMDN Term
Low ionic-strength salt solution (LISS) immunohaematology reagent IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9175 FDA UDI
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

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: Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

Mlb 2 by Bio-Rad Medical Diagnostics GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Low ionic-strength salt solution (LISS) immunohaematology reagent IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Rad Medical Diagnostics GmbH

Sources (1)

  • FDA UDI 386d3f0d-a3c6-4083-807f-1674f065285f 36 fields · synced Jun 1, 2026