AccessGUDID - DEVICE: Factor VIII Chromogenic Assay (00630414640389)

GUDID

Device Identifier (DI) Information

Brand Name: Factor VIII Chromogenic Assay
Version or Model: 10873840
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10873840
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00630414640389
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: Determination of Factor VIII (antihemophilic factor) activity in human plasma

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?
56022	Coagulation factor VIII IVD, kit, chromogenic	A collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor VIII in a clinical specimen, using a chromogenic method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGP	TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K884544	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: 18a06a3a-b5b4-466e-9948-4a32995486bb
Public Version Date: April 02, 2024
Public Version Number: 1
DI Record Publish Date: March 25, 2024