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IMMULITE® Systems BMG CONTROL Beta-2 Microglobulin

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE® Systems BMG CONTROL Beta-2 Microglobulin FDA UDI
Generic Name
Beta-2-microglobulin IVD, control FDA UDI
Device Name
B2-MICROGLOBULIN - IMMULITE - CTL - 3x1mL FDA UDI
Model / Reference
10385587 FDA UDI
Description
B2-MICROGLOBULIN - IMMULITE - CTL - 3x1mL FDA UDI

Identifiers

Catalog Number
BMCM FDA UDI
Primary DI / UDI-DI
00630414952956 FDA UDI
510(k) Number
K931702 FDA UDI
FDA Product Code
JZG FDA UDI
GMDN Term
Beta-2-microglobulin IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5630 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

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: Beta-2-microglobulin IVD, control

IMMULITE® Systems BMG CONTROL Beta-2 Microglobulin by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Beta-2-microglobulin IVD, control.

Cleared under the same submission

K931702 also covers:

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 a2baccda-52f9-4a0b-9d47-1551a8258d28 37 fields · synced Jun 1, 2026