TOTAL BILIRUBIN 2135-0

GUDID 00852223007232

TOTAL BILIRUBIN (MODIFIED MALLOY-EVELYN)

STERLING DIAGNOSTICS INC

Total bilirubin IVD, reagent

• Primary Device ID: 00852223007232
• NIH Device Record Key: 91b3af27-c122-4960-b647-27f390fb0592
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOTAL BILIRUBIN
• Version Model Number: 2135-0
• Catalog Number: 2135-0
• Company DUNS: 155284151
• Company Name: STERLING DIAGNOSTICS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852223007232 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-14

Devices Manufactured by STERLING DIAGNOSTICS INC

• 00852223007119 - UREA NITROGEN (BERTHELOT): 2018-04-17 UREA NITROGEN/COLOR (BERTHELOT)
• 00852223007126 - UREA NITROGEN (BERTHELOT): 2018-04-17 UREA NITROGEN (BERTHELOT)
• 00852223007003 - ENZYMATIC CHOLESTEROL: 2018-03-29 ENZYMATIC CHOLESTEROL (TRINDER/COD-CEH)
• 00852223007010 - ENZYMATIC CHOLESTEROL: 2018-03-29 ENZYMATIC CHOLESTEROL (TRINDER/COD-CEH)
• 00852223007027 - HDL CHOLESTEROL: 2018-03-29 HDL CHOLESTEROL (PEG METHOD)
• 00852223007034 - CPK / COLORIMETRIC: 2018-03-29 CREATINE PHOSPHOKINASE (CPK) COLORIMETRIC
• 00852223007041 - CREATININE/ ENDPOINT: 2018-03-29 CREATININE/ENDPOINT
• 00852223007058 - ENZYMATIC GLUCOSE: 2018-03-29 GLUCOSE ENZYMATIC TRINDER