DEVICE: VIROTROL (00847661002628)

Device Identifier (DI) Information

VIROTROL
00116
In Commercial Distribution
00116
BIO-RAD LABORATORIES, INC.
00847661002628
GS1

1
051624070 *Terms of Use
VIROTROL WNV (An unassayed (human) serology control.)
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
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?
49063 West Nile virus immunoglobulin A (IgA)/IgG/IgM antibody 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 immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to West Nile virus in a clinical specimen.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
OHQ Multi-analyte controls unassayed
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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

052cb3ba-cd95-4e7b-bd9b-49226e7927fa
January 31, 2023
3
September 14, 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)854-6737
qsd.techservice@bio-rad.com
CLOSE