DEVICE: M45d Test Reagent Species (05060446290248)

Device Identifier (DI) Information

M45d Test Reagent Species
M45d
In Commercial Distribution

MICROGEN BIOPRODUCTS LIMITED
05060446290248
GS1

1
231128802 *Terms of Use
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Legionella pneumophila antigen IVD, kit, agglutination A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple serogroups of Legionella pneumophila in a clinical specimen, using an agglutination method. The assay is designed to detect infection with Legionella pneumophila, the bacteria associated with Legionnaires' disease.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
CLOSE

FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

ec833c9d-f10e-4c4e-9d61-eb3de8f42e28
March 29, 2018
2
June 30, 2016
CLOSE

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
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE