DEVICE: QUANTA Flash® HMGCR Reagents (08426950793182)

Device Identifier (DI) Information

QUANTA Flash® HMGCR Reagents
701333
In Commercial Distribution

INOVA DIAGNOSTICS, INC.
08426950793182
GS1

1
188354831 *Terms of Use
1 QUANTA Flash HMGCR Reagent Cartridge. 1 Resuspension Buffer. 1 Transfer pipette.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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?
63068 3-Hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibody IVD, kit, chemiluminescent immunoassay
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) in a clinical specimen, using a chemiluminescent immunoassay method. It is used to aid the diagnosis of immune-mediated necrotizing myopathy (IMNM).
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LLL Extractable Antinuclear Antibody, Antigen And Control
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K180975 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

9171a5e6-02ee-48e2-9d5c-2c7f4d331117
December 03, 2018
1
October 31, 2018
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

[?]
1-800-545-9495
support@inovadx.com
CLOSE