AccessGUDID - DEVICE: APL™ IgM ELISA Kit (B473LAPLKAPM00)

GUDID

Device Identifier (DI) Information

Brand Name: APL™ IgM ELISA Kit
Version or Model: IgM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LAPL-K-AP-M-0
Company Name: Louisville APL Diagnostics, Inc.

Primary DI Number: B473LAPLKAPM00
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 018417647 *Terms of Use

Device Description: The APL™ IgM ELISA Kit is designed for the measurement of anticardiolipin antibodies of the IgM isotype.

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?
55085	Phospholipid 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 antiphospholipid antibodies associated with antiphospholipid syndrome, 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 [?]
Premarket Submission Number Not Available/Not Released

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: 612b7a7e-c03e-4646-9110-e9fc6b149ae6
Public Version Date: January 03, 2023
Public Version Number: 1
DI Record Publish Date: December 26, 2022