AccessGUDID - DEVICE: Benzodiazepine DAU Calibrator/Control, Calibrator #3/Cutoff A/Control 2 (B07601330)

GUDID

Device Identifier (DI) Information

Brand Name: Benzodiazepine DAU Calibrator/Control, Calibrator #3/Cutoff A/Control 2
Version or Model: 0133
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0133
Company Name: LIN-ZHI INTERNATIONAL, INC.

Primary DI Number: B07601330
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 840839190 *Terms of Use

Device Description: 5mL/bottle. Concentration: 200 ng/mL of Oxazepam.

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
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
55526	Benzodiazepine group IVD, calibrator	A material which is used to establish known points of reference for 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
DLJ	Calibrators, Drug Specific

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032365	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 35f87478-e7ae-4ff8-b005-739fe33537e8
Public Version Date: August 24, 2018
Public Version Number: 4
DI Record Publish Date: July 05, 2016