AccessGUDID - DEVICE: Bordetella pertussis IgG ELISA (B24220BPGHUE010)

GUDID

Device Identifier (DI) Information

Brand Name: Bordetella pertussis IgG ELISA
Version or Model: 20-BPGHU-E01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20-BPGHU-E01
Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Primary DI Number: B24220BPGHUE010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784143778 *Terms of Use

Device Description: The Bordetella pertussis / toxin IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Bordetella pertussis and Bordetella pertussis toxin in serum. This assay is intended for in vitro diagnostic use.

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?
50521	Bordetella pertussis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Bordetella pertussis in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Bordetella pertussis, the bacteria associated with whooping cough.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GOX	Antigen, B. Pertussis

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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b29a5d85-66e5-47e7-84dd-1e4482339038
Public Version Date: June 26, 2020
Public Version Number: 1
DI Record Publish Date: June 18, 2020