AccessGUDID - DEVICE: Lyphochek (00847661002130)

GUDID

Device Identifier (DI) Information

Brand Name: Lyphochek
Version or Model: 660X
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 660X
Company Name: BIO-RAD LABORATORIES, INC.

Primary DI Number: 00847661002130
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051624070 *Terms of Use

Device Description: Lyphochek Benzo/TCA Control- Set A MiniPak (A human serum assayed benzodiazepines and TCA control.)

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):	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?
55817	Tricyclic antidepressant IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of tricyclic antidepressant drugs in a clinical specimen.	Active	false
55527	Benzodiazepine group IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple benzodiazepines in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LAS	DRUG SPECIFIC CONTROL MATERIALS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K910829	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: 59df36b2-d6dc-4989-b82c-69d7ea1f0686
Public Version Date: January 31, 2023
Public Version Number: 5
DI Record Publish Date: January 09, 2017