FDA.reportPublic FDA data

μTASWako AFP-L3 Calibrator Set

Primary DI
00085662006168
Brand
μTASWako AFP-L3 Calibrator Set
Company
WAKO LIFE SCIENCES, INC.
Model
997-60901
Catalog number
997-60901
Device description
In-Vitro Diagnostic Use
Published
2016-11-25
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JITCalibrator, Secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100464000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100464000UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTIONWako Chemicals USA, Inc.2011-02-23NSF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00085662006168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00085662006168000856620061680856620061680085662006168

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, calibratorA material used to establish known points of reference for an assay intended to qualitatively and/or quantitatively detect alpha-fetoprotein-L3 fraction (AFP-L3) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-714-1924diagnostics@wakousa.com

Regulatory Flags#

DUNS number
078629716
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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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