FDA.reportPublic FDA data

ENVOY 500 SERUM CONTROL KIT

Primary DI
03661540201806
Brand
ENVOY 500 SERUM CONTROL KIT
Company
VITALSCIENTIFIC
Model
55131
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540201806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540201806036615402018063661540201806

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type clinical chemistry analyte profile IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
267732378
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540214707GAMMA-GT SZASZ SLGZSL-02502016-09-24
03701700817802ELICAL 2 CALI-05502026-03-04
03701700819400ELITROL ICONT-00602026-03-04
03701700819509ELITROL IICONT-01602026-03-04
03701700800347LDL CALIBRATOR KIT551152026-02-12
03701700800354HDL CALIBRATOR KIT551192026-02-12
03701700821106HbA1c CALIBRATOR SET HBAC-00432026-01-19
03701700821205HbA1c CONTROL L+ HHBAC-00492026-01-19
03701700800019ENVOY 500 ALBUMIN REAGENT KIT552252025-03-31
03701700815006ALBUMINALBU-02502025-03-31
03701700800026ENVOY 500 ALT REAGENT KIT552152025-03-31
03701700800033ENVOY 500 AMYLASE REAGENT KIT552452025-03-31
03701700800040ENVOY 500 AST REAGENT KIT552502025-03-31
03701700800057ENVOY 500 URIC ACID REAG.KIT554502025-03-31
03701700800064ENVOY 500 DIRECT BILIRUBIN REAGENT KIT552602025-03-31
03701700800071ENVOY 500 TOTAL BILIRUBIN REAGENT KIT552702025-03-31
03701700800088ENVOY 500 CALCIUM REAGENT KIT552872025-03-31
03701700800095ENVOY 500 SERUM CALIBRATOR KIT551112025-03-31
03701700800101ENVOY 500 CHOLESTEROL REAGENT KIT552972025-03-31
03701700800125ENVOY 500 SERUM CONTROL KIT551312025-03-31