AccessGUDID - DEVICE: IMMULITE® 2000 Systems BcM Anti-HBc IgM (00630414977737)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE® 2000 Systems BcM Anti-HBc IgM
Version or Model: 10488616
Commercial Distribution Status: In Commercial Distribution
Catalog Number: L2KMC2(D)
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414977737
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: BcM Anti-HBc IgM Kit 200 Test

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48298	Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the Hepatitis B virus core antigen in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LOM	Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P010053	001
P010053	004
P010053	006
P010053	007

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Protect from Light

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 49ad2ad5-e036-4538-922f-e5aa54fa99a3
Public Version Date: November 18, 2021
Public Version Number: 7
DI Record Publish Date: September 24, 2014