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N Antiserum to Human a2-Macroglobulin

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
N Antiserum to Human a2-Macroglobulin FDA UDI
Generic Name
Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name
Quantitative determination of a2-macroglobulin in human serum and plasma on BN Systems FDA UDI
Model / Reference
10469773 FDA UDI
Description
Quantitative determination of a2-macroglobulin in human serum and plasma on BN Systems FDA UDI

Identifiers

Catalog Number
OSAM21 FDA UDI
Primary DI / UDI-DI
00842768029967 FDA UDI
510(k) Number
K053073 FDA UDI
FDA Product Code
DEB FDA UDI
GMDN Term
Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5620 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

No

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: Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry

N Antiserum to Human a2-Macroglobulin by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics Products Ltd

Sources (1)

  • FDA UDI ba56418e-4a1a-42f7-be90-927ac17f66ec 37 fields · synced May 30, 2026