DEVICE: RDS (10694644700012)

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Device Record History
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Device Identifier (DI) Information
RDS
10-RSV-060
In Commercial Distribution
10-RSV-060
AMERICAN BIO MEDICA CORPORATION
10694644700012
GS1

20
966665036 *Terms of Use
RSV Test Kit US Version 135060
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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?
48263 Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of antigens from influenza viruses (e.g., influenza A, influenza B) and respiratory syncytial virus (RSV) in a clinical specimen.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K021789 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 15 and 30 Degrees Celsius
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Temperature: between 59 and 86 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
d8660a05-8718-4500-bb22-dd8122cf4905
July 06, 2018
3
September 23, 2016
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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

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

[?]
Unit of Use DI Number: 10694644750017 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
518-758-8158
customerservice@abmc.com
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