AccessGUDID - DEVICE: Borrelia B31 ViraChip IgM Deca Kit (EVIRBBCMDK1)

GUDID

Device Identifier (DI) Information

Brand Name: Borrelia B31 ViraChip IgM Deca Kit
Version or Model: V-BBCMDK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: V-BBCMDK
Company Name: Viramed Biotech AG

Primary DI Number: EVIRBBCMDK1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 329748847 *Terms of Use

Device Description: Immunoassay for the detection of IgM antibodies against Borrelia burgdorferi s.s. / B31 im human serum.

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:	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?
50555	Borrelia burgdorferi total antibody IVD, kit, immunoblot	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Borrelia burgdorferi in a clinical specimen, using an immunoblot method. The assay is designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LSR	Reagent, Borrelia Serological Reagent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163695	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
Device Size Text, specify: 960 tests

Device Record Status

Public Device Record Key: d628452c-5691-4351-86ee-fc7d2c138fae
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 12, 2018