← Back to catalogue

IMMULITE® 2000 Systems HBsAg Confirmatory Kit

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
IMMULITE® 2000 Systems HBsAg Confirmatory Kit FDA UDI
Generic Name
Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
HBsAg Confirmatory Kit 100 Test FDA UDI
Model / Reference
10706825 FDA UDI
Description
HBsAg Confirmatory Kit 100 Test FDA UDI

Identifiers

Catalog Number
L2KCH1(D) FDA UDI
Primary DI / UDI-DI
00630414947433 FDA UDI
PMA Number
P010050 FDA UDI
FDA Product Code
LOM FDA UDI
GMDN Term
Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3172 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: Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems HBsAg Confirmatory Kit by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

P010050 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Siemens Healthcare Diagnostics Products Ltd

Sources (1)

  • FDA UDI 2fddc049-9195-4b50-8171-83f0fcf5d6d0 37 fields · synced May 30, 2026