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Dimension Vista® BHCG CAL

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension Vista® BHCG CAL FDA UDI
Generic Name
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, calibrator FDA UDI
Device Name
Beta Human Chorionic Gonadotropin Calibrator, 2x4x1mL / 2x2mL / 2x1.5mL FDA UDI
Model / Reference
10445192 FDA UDI
Description
Beta Human Chorionic Gonadotropin Calibrator, 2x4x1mL / 2x2mL / 2x1.5mL FDA UDI

Identifiers

Catalog Number
KC632 FDA UDI
Primary DI / UDI-DI
00842768016516 FDA UDI
510(k) Number
K063754 FDA UDI
FDA Product Code
JIT FDA UDI
GMDN Term
Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 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: Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, calibrator

Dimension Vista® BHCG CAL by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, calibrator.

Cleared under the same submission

K063754 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI fd945b91-3e3b-4fe5-8ac1-acd2e04dd0da 37 fields · synced Jun 8, 2026