AccessGUDID - DEVICE: Abnormal HbA2 Quik Column Control (M52553330)

GUDID

Device Identifier (DI) Information

Brand Name: Abnormal HbA2 Quik Column Control
Version or Model: 5333
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: HELENA LABORATORIES CORPORATION

Primary DI Number: M52553330
Issuing Agency: HIBCC
Commercial Distribution End Date: February 28, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 079396131 *Terms of Use

Device Description: No description.

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):	Yes
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?
59803	Inherited haemoglobinopathy IVD, control	A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited haemoglobinopathies or haemoglobin variants, which may be associated with HbC (haemoglobin C), HbE, HbS (sickle-cell disease), Hb Lepore, Hb constant spring, alpha-thalassaemia and/or beta-thalassaemia.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JCM	CONTROL, HEMOGLOBIN, ABNORMAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K820787	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cf383954-097d-4091-85de-1ee2c0fdc366
Public Version Date: November 28, 2019
Public Version Number: 4
DI Record Publish Date: September 07, 2016