DEVICE: Atellica IM aHAVM QC (00630414597744)

Device Identifier (DI) Information

Atellica IM aHAVM QC
10995445
In Commercial Distribution
10995445
Siemens Healthcare Diagnostics Inc.
00630414597744
GS1

1
064608573 *Terms of Use
HAV IgM Ab (aHAVM) QC Kit Atellica IM - CLT 2x2x7mL
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
41960 Hepatitis A virus immunoglobulin M (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 M (IgM) antibodies to the Hepatitis A virus in a clinical specimen.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LOL Hepatitis a test (antibody and igm antibody)
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P040018 000
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store Upright, Protect from Light, Do not freeze, Resuspend.
Storage Environment Temperature: between 2 and 8 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

7f45bc5c-bfee-4cc1-81ab-6c2f3c66412e
February 16, 2022
6
December 27, 2017
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(877)229-3711
CONTACT@SIEMENS-HEALTHINEERS.COM
CLOSE