AccessGUDID - DEVICE: VITROS (10758750034567)

GUDID

Device Identifier (DI) Information

Brand Name: VITROS
Version or Model: 6199975
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6199975
Company Name: ORTHO-CLINICAL DIAGNOSTICS, INC.

Primary DI Number: 10758750034567
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 623873044 *Terms of Use

Device Description: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64865	SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a chemiluminescent immunoassay method. This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QKO	Reagent, coronavirus serological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do not freeze
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bfb2381b-5817-4ddb-bf73-bde5592e527a
Public Version Date: November 16, 2021
Public Version Number: 1
DI Record Publish Date: November 08, 2021

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)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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