AccessGUDID - DEVICE: Clinitek Novus® Cal 1-4 kit (00630414590950)

GUDID

Device Identifier (DI) Information

Brand Name: Clinitek Novus® Cal 1-4 kit
Version or Model: 10697753
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10697753
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414590950
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Clinitek Novus® calibration kit for use with CLINITEK Novus® automated urine chemistry system

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):	No
Over the Counter (OTC):	No
Kit:	No
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?
52836	Multiple Schistosoma species immunoglobulin G (IgG) antibody 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 immunoglobulin G (IgG) antibodies to multiple species of the parasitic flatworm Schistosoma in a clinical specimen.	Active	false

FDA Product Code

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Product Code	Product Code Name
JMT	DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)
KQO	AUTOMATED URINALYSIS SYSTEM
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE
JJB	AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
CDM	DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
JIO	BLOOD, OCCULT, COLORIMETRIC, IN URINE
JIL	METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
JIN	NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
JIR	INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
LJX	TEST, URINE LEUKOCYTE
CEN	DYE-INDICATOR, PH (URINARY, NON-QUANT.)
JRE	REFRACTOMETER FOR CLINICAL USE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140717	000

Device Exempt from Premarket Submission: No 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: Keep Dry, Keep refrigerated and do not freeze
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8495137e-f0b4-47e7-88f7-d8009fb3f3c2
Public Version Date: June 02, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016