DEVICE: KOVA (00855617006934)
Device Identifier (DI) Information
KOVA
87141
In Commercial Distribution
87141
KOVA INTERNATIONAL, INC.
87141
In Commercial Distribution
87141
KOVA INTERNATIONAL, INC.
KO-LEC-PAC, 500 Determinations
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? |
---|---|---|---|---|
43761 | Centrifuge tube IVD |
A tube intended to be used in the laboratory to contain a clinical specimen, reagent, or other material associated with in vitro diagnostic testing, for separation by centrifugation. It is designed to be placed in a centrifuge rotor for the procedure; it may also be placed in a rack for short-term storage of its contents. It is typically transparent to facilitate observation of its contents, frequently includes a cap (e.g., screw or press-fit), and may have graduations along the side. This is a single-use device.
|
Active | false |
43375 | User-induced pipette |
A device designed for the manual withdrawal, transfer, and injection of small volumes of fluid materials. It is made of glass or plastic and is designed as a long thin tube, typically with graduations along its length. The user will typically attach a mouthpiece and create a partial vacuum within the pipette by gently sucking the air from inside the tube inducing the liquid to enter the pipette, or achieve the same action with a squeezable bulb. Closing the mouthpiece or the user end of the pipette will hold the liquid therein; dispensing is done by controlled venting of air into the user end or squeezing the bulb.
|
Active | false |
57925 | General specimen microscopy slide IVD, single-use |
A glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NNK | Container, Specimen Mailer And Storage, Non-Sterile |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
9c885c8f-1522-4462-9a52-0c509cc9258c
December 22, 2021
2
August 11, 2020
December 22, 2021
2
August 11, 2020
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
714-902-1700
cs@kovaintl.com
cs@kovaintl.com