AccessGUDID - DEVICE: ASI RPR Dispensing Bottle (00816057021246)

GUDID

Device Identifier (DI) Information

Brand Name: ASI RPR Dispensing Bottle
Version or Model: NC-90900210
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NC-90900210
Company Name: ARLINGTON SCIENTIFIC, INC.

Primary DI Number: 00816057021246
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 785966607 *Terms of Use

Device Description: Detection of Syphilis

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:	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?
51819	Treponema pallidum reagin antibody IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen using an agglutination method [for example Rapid Plasma Reagin (RPR) test or Venereal Disease Research Laboratory (VDRL) test]. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GMP	Antisera, Control For Nontreponemal Tests

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K851504	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
Special Storage Condition, Specify: Room Temp

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 3 Milliliter

Device Record Status

Public Device Record Key: 096a6d4f-6314-4f28-a737-4d1b4f9ea120
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 08, 2016