AccessGUDID - DEVICE: AIX1000 Analyzer (B350004000)

GUDID

Device Identifier (DI) Information

Brand Name: AIX1000 Analyzer
Version or Model: 00400
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gold Standard Diagnostics Corporation

Primary DI Number: B350004000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790524891 *Terms of Use

Device Description: AIX1000 Rapid Plasma Reagin (RPR) Analyzer

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?
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
64179	Agglutination assay digital imaging reader/analyser IVD	An electrically-powered laboratory instrument designed to be used to capture digital images of a clinical specimen from a dedicated specimen slide/cartridge/card and provide image analysis of an agglutination or haemagglutination assay. It is a benchtop instrument that includes a tray, slot or drawer, where the specimen is placed for optical image acquisition, and dedicated software for analysis, visualization and storage of the acquired images.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GMQ	Antigens, Nontreponemal, All

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150358	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: 8dc581b9-91f9-484d-9731-e4bdc3ab8a8e
Public Version Date: October 18, 2024
Public Version Number: 5
DI Record Publish Date: November 29, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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