FDA.reportPublic FDA data

ISE Serum Standard Set NA

Primary DI
04987762129889
Brand
ISE Serum Standard Set NA
Company
JEOL LTD.
Model
781611351
Published
2020-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JIXCalibrator, Multi-Analyte Mixture
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987762129889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987762129889049877621298894987762129889

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry enzyme IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple clinical chemistry enzymes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690565023
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987762129759ISE Buffer (IS)7816113342020-10-09
04987762129766Reagent Probe Wash S7816114822020-09-15
04987762129773Reagent Probe Wash K7816114742020-09-15
04987762129780Reagent Probe Wash 27816114662020-09-15
04987762129797Reagent Probe Wash 17816114582020-09-15
04987762129810Cuvette Conditioner EX7816114312020-09-15
04987762129827Cuvette Wash Solution 77816114232020-09-15
04987762129834ISE Detergent Solution7816114152020-09-15
04987762129896Internal Standard7816113422020-09-15
04987762129902ISE Urine Standard Set7816113692020-09-15
04987762129803Lamp Coolant C7816114402020-09-15
04987762129841Reference Electrode7816114072020-09-15
04987762129858Chloride Electrode7816113932020-09-15
04987762129865Potassium Electrode7816113852020-09-15
04987762129872Sodium Electrode7816113772020-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810053950104NOVEOS Soybean, Glycine maxHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950111NOVEOS Hazelnut, Corylus avellanaHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950135NOVEOS Almond, Amygdalus communisHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950296NOVEOS Bos d 8 Casein, MilkHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950319NOVEOS Lobster, Homarus gammarusHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950449NOVEOS Ara h 8 PR-10, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950456NOVEOS Ara h 1, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950463NOVEOS Ara h 2, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950494NOVEOS Ara h 6, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879023770NOVEOS Sesame Seed, Sesamum indicumHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024203NOVEOS Lobster, Homarus gammarusHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024333NOVEOS Ara h 1, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024470NOVEOS Bos d 8 Casein, MilkHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024982NOVEOS Ara h 2, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879025323NOVEOS Ara h 8 PR-10, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879025354NOVEOS Soybean, Glycine maxHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879025378NOVEOS Ara h 6, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879027341NOVEOS Hazelnut, Corylus avellanaHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879027969NOVEOS Almond, Amygdalus communisHYCOR BIOMEDICAL LLCJJE2026-07-29
08430793040839Aptiva® APS IgA CalibratorsINOVA DIAGNOSTICS, INC.JIX2026-06-10
00810053950128NOVEOS Brazil Nut, Bertholletia excelsaHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950203NOVEOS Coconut, Cocos nuciferaHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950210NOVEOS Tuna, Thunnus sp.HYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950227NOVEOS Salmon, Salmo salarHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950265NOVEOS Egg Yolk, Gallus gallusHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950340NOVEOS Pecan Nut, Carya illinoensisHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950364NOVEOS Pistachio Nut, Pistacia veraHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950418NOVEOS Oyster, Ostrea edulisHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879023794NOVEOS Brazil Nut, Bertholletia excelsaHYCOR BIOMEDICAL LLCJJE2026-05-29