DEVICE: DG Health One Step Pregnancy Test (00430000702077)
Device Identifier (DI) Information
DG Health One Step Pregnancy Test
FHC-102H
Not in Commercial Distribution
DOLGENCORP, LLC
FHC-102H
Not in Commercial Distribution
DOLGENCORP, LLC
FHC-102H Dollar General Preg One Step Cassette
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
33819 | Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical |
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)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 within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid detection of pregnancy, or as a predictor of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). It is not intended to be used for self-testing.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K012215 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f1234d07-e812-41f1-a6da-0aa568982c77
September 07, 2023
5
June 30, 2016
September 07, 2023
5
June 30, 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 |
---|---|---|---|---|---|
10430000702074 | 96 | 00430000702077 | 2023-09-06 | Not in Commercial Distribution | Shipping Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
888-309-9030
xx@xx.xx
xx@xx.xx