AccessGUDID - DEVICE: Tina-quant a1-Antitrypsin ver.2 (07613336130230)

GUDID

Device Identifier (DI) Information

Brand Name: Tina-quant a1-Antitrypsin ver.2
Version or Model: 08101396190
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08101396190
Company Name: Roche Diagnostics GmbH

Primary DI Number: 07613336130230
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *Terms of Use

Device Description: No description.

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:	Yes
Prescription Use (Rx):	Yes
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?
53602	Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-1-antitrypsin (protease inhibitor) in a clinical specimen, using a nephelometry/turbidimetry method. Alpha-1-antitrypsin deficiency is typically associated with liver cirrhosis and pulmonary emphysema.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DEM	ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K010978	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: db004665-ebf5-4b56-857b-804f212c4fdb
Public Version Date: March 13, 2020
Public Version Number: 1
DI Record Publish Date: March 05, 2020