AccessGUDID - DEVICE: Trinity Biotech (05391516746182)

GUDID

Device Identifier (DI) Information

Brand Name: Trinity Biotech
Version or Model: 32-5100G
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 32-5100G
Company Name: MARDX DIAGNOSTICS, INC.

Primary DI Number: 05391516746182
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 154281349 *Terms of Use

Device Description: Lyme Disease IgG IFA Test System (100 Tests)

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:	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?
50538	Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to multiple species of Borrelia in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Borrelia bacteria which may include B. afzelii, B. burgdorferi and/or B. garinii that are 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 [?]
K890053	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: a086c3c1-ec51-4fa8-8974-adc7978cf1fd
Public Version Date: August 09, 2021
Public Version Number: 4
DI Record Publish Date: September 18, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800-325-3424
Email: info@trinitybiotech.com

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