DEVICE: CVS Health Early Result Pregnancy Test (00050428329375)
Device Identifier (DI) Information
CVS Health Early Result Pregnancy Test
PLPL
In Commercial Distribution
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
PLPL
In Commercial Distribution
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
CVS DPS Early Result
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid | 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 may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses. |
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 [?] |
---|---|
K042280 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
bee06420-ee82-42b6-bce9-aa53cb2b60f0
July 06, 2018
3
June 30, 2016
July 06, 2018
3
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 |
---|---|---|---|---|---|
10050428329372 | 24 | 00050428329375 | In Commercial Distribution | Shipping Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00633472000126
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-899-7353
xx@xx.xx
xx@xx.xx