AccessGUDID - DEVICE: ACON SARS-CoV-2 IgG/IgM Rapid Test (00682607200979)

GUDID

Device Identifier (DI) Information

Brand Name: ACON SARS-CoV-2 IgG/IgM Rapid Test
Version or Model: L031-11711
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200979
Company Name: ACON LABORATORIES, INC.

Primary DI Number: 00682607200979
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 781100966 *Terms of Use

Device Description: Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25)

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:	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?
64756	SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QKO	Reagent, coronavirus serological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 30 Degrees Celsius
Special Storage Condition, Specify: The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6244f1ab-86ac-4a61-ae08-470358c4c934
Public Version Date: June 10, 2022
Public Version Number: 2
DI Record Publish Date: February 08, 2021