DEVICE: i-STAT (10054749001009)
Device Identifier (DI) Information
i-STAT
05p58-25
In Commercial Distribution
05p58-25
ABBOTT POINT OF CARE INC.
05p58-25
In Commercial Distribution
05p58-25
ABBOTT POINT OF CARE INC.
CARTRIDGE, Total B-hCG
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
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? |
---|---|---|---|---|
54212 | Total human chorionic gonadotropin IVD, reagent |
A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DHA | System, Test, Human Chorionic Gonadotropin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K133002 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 2 and 8 Degrees Celsius |
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
55322f58-51af-4fcf-997f-63ce51f9338d
September 11, 2023
4
September 09, 2016
September 11, 2023
4
September 09, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00054749001002 | 25 | 10054749001009 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)366-8020
techsvc@apoc.abbott.com
techsvc@apoc.abbott.com