AccessGUDID - DEVICE: AllergiEnd ST-9 (B6821001360)

GUDID

Device Identifier (DI) Information

Brand Name: AllergiEnd ST-9
Version or Model: 1001-36
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1001-36
Company Name: MEDSCIENCE RESEARCH GROUP, INC.

Primary DI Number: B6821001360
Issuing Agency: HIBCC
Commercial Distribution End Date: August 30, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 013114656 *Terms of Use

Device Description: 36 Well Test Tray

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):	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?
61298	General laboratory assay tray	A tray with multiple wells designed to contain volumes of reagents, buffers, and other materials for laboratory testing procedures (e.g., in vitro diagnostic) performed manually, or by a laboratory analyser. The wells may in addition be used to contain and mix reactants for reactions performed onboard the analyser. It is typically made of plastic (e.g., polypropylene) and is used with manual or automated liquid handling instruments or analysers. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDH	System, Delivery, Allergen And Vaccine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172062	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -20 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2923802c-d67d-409d-90f5-4a40396ddca0
Public Version Date: August 30, 2021
Public Version Number: 3
DI Record Publish Date: November 30, 2018