DEVICE: Low-Tox-H Rabbit Complement (00628451099208)

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Device Record History
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Device Identifier (DI) Information
Low-Tox-H Rabbit Complement
CL3335
In Commercial Distribution
CL3335
Cedarlane Corporation
00628451099208
GS1

1
243928822 *Terms of Use
06284510990202
Low-Tox®-H Rabbit Complement, Lyophilized
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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?
58366 Complement reagent IVD
A solution containing complement proteins intended to be used alone or in combination with other IVDs in the processing, staining and/or testing of clinical laboratory specimens. Typical uses may include HLA tissue typing by a complement-dependent cytotoxicity (CDC) method, or antigen-antibody based reactions by complement fixation test (CFT).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KTQ Reagent, Complement
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: exactly -20 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 10 Milliliter
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Device Record Status
accf12a8-36cc-4fee-9a4e-fa669a3921dd
December 18, 2024
1
December 10, 2024
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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

[?]
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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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