AccessGUDID - DEVICE: Lyphochek (00847661005759)

GUDID

Device Identifier (DI) Information

Brand Name: Lyphochek
Version or Model: 12000144
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12000144
Company Name: BIO-RAD LABORATORIES, INC.

Primary DI Number: 00847661005759
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051624070 *Terms of Use

Device Description: Lyphochek Allergen sIgE Control Panel A MiniPak (An assayed human serum allergen sIgE 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?
41351	Multiple allergen-specific immunoglobulin E (IgE) antibody 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 immunoglobulin E (IgE) antibodies to multiple specific protein allergens in a clinical specimen.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-analyte controls, all kinds (assayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K134013	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: 7d2f6e11-eb21-47f3-82a7-b4a7205e00ea
Public Version Date: September 22, 2020
Public Version Number: 1
DI Record Publish Date: September 14, 2020