AccessGUDID - DEVICE: N Antiserum to Human Haptoglobin (00842768009853)

GUDID

Device Identifier (DI) Information

Brand Name: N Antiserum to Human Haptoglobin
Version or Model: 10446304
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OSAV09
Company Name: Siemens Healthcare Diagnostics Products GmbH

Primary DI Number: 00842768009853
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 388240673 *Terms of Use

Device Description: Quantitative determination of haptoglobin in human serum and plasma on BN Systems

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
CFN	METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K860894	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: fb822dc2-1681-40d1-baff-0623e6569cf2
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016