DEVICE: CVS Health Digital + Early Result Pregnancy Test Kit (00050428414422)
Device Identifier (DI) Information
CVS Health Digital + Early Result Pregnancy Test Kit
CB8 + PLPL
In Commercial Distribution
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
CB8 + PLPL
In Commercial Distribution
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
A convenience kit consisting of 1 CVS Pregnancy Digital Pregnancy Test and 1 CVS Early Result Pregnancy Test
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
Yes | |
Yes | |
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 |
K060128 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
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
b60bc028-2512-4152-af20-6df269394e6f
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 |
---|---|---|---|---|---|
10050428414429 | 24 | 00050428414422 | 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
[?]
800-899-7353
xx@xx.xx
xx@xx.xx