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Human IgA2 Subclass Liquid Latex Reagent Kit for use on the Siemens BN™II

FDA UDI

Class II (US FDA UDI)

by The Binding Site Group

Identity

Trade Name
Human IgA2 Subclass Liquid Latex Reagent Kit for use on the Siemens BN™II FDA UDI
Generic Name
Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry FDA UDI
Model / Reference
LK088.1T FDA UDI

Identifiers

Primary DI / UDI-DI
05051700006538 FDA UDI
510(k) Number
K981912 FDA UDI
FDA Product Code
CFN FDA UDI
GMDN Term
Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5510 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

No

FDA UDI

Category: Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Human IgA2 Subclass Liquid Latex Reagent Kit for use on the Siemens BN™II by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry.

Cleared under the same submission

K981912 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
The Binding Site Group

Sources (1)

  • FDA UDI 7780d76d-bea6-4bc7-bcbd-83e8dfa40642 35 fields · synced May 30, 2026