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.
00816870021027
GS1

1
083155515 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CFT RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K971921 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Handling Environment Temperature
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Clinically Relevant Size

[?]
Size Type Text
Width: 7.75 Inch
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Device Record Status

4f79d15e-1ecb-4b77-bcb4-2755e6b09982
March 11, 2019
1
February 11, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(949)951-2665
info@monobind.com
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