DEVICE: Autostat II IgA Rheumatoid Factor (00081687902006)

Device Identifier (DI) Information

Autostat II IgA Rheumatoid Factor
FGA06
In Commercial Distribution

HYCOR BIOMEDICAL LLC
00081687902006
GS1

1
010558476 *Terms of Use
96 well ELISA for the detection of IgA Rheumatoid Factor antibodies in human serum.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
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
Rheumatoid factor IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of rheumatoid factor immunoglobulins in a clinical specimen, using an enzyme immunoassay (EIA) method.
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FDA Product Code

[?]
Product Code Product Code Name
DHR System, Test, Rheumatoid Factor
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K993557 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
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

337ed5da-0412-49b5-8ce7-9df8e5c5af39
July 06, 2018
3
September 26, 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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
800-382-2527
Customerservices-us@hycorbiomedical.com
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