DEVICE: FLU/RSV Positive Control (00840733101977)

Device Identifier (DI) Information

FLU/RSV Positive Control
751110
Not in Commercial Distribution
751110
MERIDIAN BIOSCIENCE, INC.
00840733101977
GS1
May 13, 2021
1
092815364 *Terms of Use
FLU/RSV Positive Control is an external control reagent to be used with TRU FLU and TRU RSV Test Kits as part of a routine quality control program
CLOSE

Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
48264 Influenza virus/respiratory syncytial virus (RSV) antigen IVD, control
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from influenza viruses (e.g., influenza A, influenza B) and respiratory syncytial virus (RSV) in a clinical specimen.
Obsolete false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K071101 000
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

db9fefcd-9c8a-4a2d-9bc9-a746f737af0d
June 21, 2021
2
November 17, 2020
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

[?]
1-800-343-3858
MBI-TechService@meridianbioscience.com
CLOSE