FDA.report

Elecsys CalCheck FT 3

Primary DI
04015630997299
Brand
Elecsys CalCheck FT 3
Company
Roche Diagnostics GmbH
Model
3554538190
Catalog number
3554538190
Published
2021-01-18
Public version status
New
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

Product Codes

CodeName
JJXSingle (specified) analyte controls (assayed and unassayed)

Product Code Classifications

CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04015630997299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04015630997299040156309972994015630997299

GMDN Terms

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

Regulatory Flags

DUNS number
315028860
Device count
1
DM exempt
false
Premarket exempt
true
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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