AccessGUDID - DEVICE: ADVIA® Chemistry HAPT Haptoglobin Reagents (00630414491356)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA® Chemistry HAPT Haptoglobin Reagents
Version or Model: 10323850
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6149314
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414491356
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Haptoglobin - ADVIA Chem. - RGT - 540 tests

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?
53737	Haptoglobin IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of haptoglobin in a clinical specimen, using a nephelometry/turbidimetry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DAD	HAPTOGLOBIN, ANTIGEN, ANTISERUM, CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: Do not freeze
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: 9dc4a6c8-33b6-428b-ba21-d9fc8481f6a7
Public Version Date: August 04, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2016