AccessGUDID - DEVICE: EL-B2GPI IgM, IgG, IgA (00854473003040)

GUDID

Device Identifier (DI) Information

Brand Name: EL-B2GPI IgM, IgG, IgA
Version or Model: 401-404
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 401-404
Company Name: THERA-TEST LABORATORIES, INC

Primary DI Number: 00854473003040
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 194336954 *Terms of Use

Device Description: ANTI-BETA 2 GLYCOPROTEIN I ANTIBODY ELISA TEST KIT IgM, IgG, IgA, 192 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:	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?
54874	Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple classes of antibodies to cardiolipin-B2-glycoprotein I complex in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092757	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: bb765d63-e2ea-42b9-a69c-b41ac0b07eba
Public Version Date: July 07, 2023
Public Version Number: 3
DI Record Publish Date: August 15, 2016