AccessGUDID - DEVICE: LA Control Low (00630414640013)

GUDID

Device Identifier (DI) Information

Brand Name: LA Control Low
Version or Model: 10873935
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10873935
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00630414640013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays

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:	No
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?
46029	Lupus anticoagulant marker IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple Lupus anticoagulant markers in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGC	Control, plasma, abnormal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993332	000

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 06a5ea9d-9413-4dde-833b-dc99886158a6
Public Version Date: April 08, 2024
Public Version Number: 1
DI Record Publish Date: March 29, 2024