AccessGUDID - DEVICE: Berichrom a2-Antiplasmin (00630414639437)

GUDID

Device Identifier (DI) Information

Brand Name: Berichrom a2-Antiplasmin
Version or Model: 10873884
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10873884
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00630414639437
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: Quantative determination of a2-antiplasmin activity as an aid in the diagnosis of inherited or acquired deficiencies and in management of fibrinolytic therapy

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?
62186	Alpha-2-antiplasmin IVD, kit, chromogenic	A collection of reagents and other associated materials intended to be used for the quantitative detection of alpha-2-antiplasmin in a clinical specimen, using a chromogenic method. It is typically used in the diagnosis of congenital bleeding disorders or disseminated intravascular coagulation (DIC) and may be used to assess response to fibrinolytic therapy.	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 [?]
K884797	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: 3e00dd8c-c88c-4eb4-b589-94fd2a2343ea
Public Version Date: April 02, 2024
Public Version Number: 1
DI Record Publish Date: March 25, 2024