FDA.report

Total & Direct Bilirubin LiquiColor®

Primary DI
00657498000601
Brand
Total & Direct Bilirubin LiquiColor®
Company
STANBIO LABORATORY, L.P.
Model
0260-200
Catalog number
0260-200
Device description
For the Quantitative Colorimetric Determination of Total and Direct Bilirubin in Serum or Plasma.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CIGDiazo Colorimetry, Bilirubin

Product Code Classifications

CodeDeviceSpecialtyClass
CIGDiazo Colorimetry, BilirubinClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00657498000601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498000601006574980006016574980006010657498000601

GMDN Terms

TermDefinition
Total bilirubin IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total bilirubin in a clinical specimen, using a spectrophotometry method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags

DUNS number
045361136
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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