DEVICE: Monobind AccuBind PRL ELISA Kit - 96 Wells (00816870021027)
Device Identifier (DI) Information
Monobind AccuBind PRL ELISA Kit - 96 Wells
725-300
In Commercial Distribution
725-300A
MONOBIND, INC.
725-300
In Commercial Distribution
725-300A
MONOBIND, INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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58351 | Pregnancy-associated plasma protein A (PAPP-A) IVD, kit, radioimmunoassay |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of pregnancy associated plasma protein A (PAPP-A) in a clinical specimen, using a radioimmunoassay method. It is used in foetal screening of Down syndrome and other chromosomal abnormalities during pregnancy.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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CFT | RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K971921 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify: Handling Environment Temperature |
Clinically Relevant Size
[?]Size Type Text |
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Width: 7.75 Inch |
Device Record Status
4f79d15e-1ecb-4b77-bcb4-2755e6b09982
March 11, 2019
1
February 11, 2019
March 11, 2019
1
February 11, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
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
[?]
+1(949)951-2665
info@monobind.com
info@monobind.com