FDA.reportPublic FDA data

BIOBASE

Primary DI
06936895301684
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
UA-510
Published
2023-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936895301684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936895301684069368953016846936895301684

GMDN Terms#

Term, Definition table
TermDefinition
Urine analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420046355
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936895315780BIOBASEDBI-32026-07-30
06936895300298BIOBASEBK5002023-07-04
06971674861201BIOBASEBK12002023-07-04
06971674861218BIOBASEBK6002023-07-04
06971674861225BIOBASEBK4002023-07-04
06971674861232BIOBASEBK2802023-07-04
06971674861249BIOBASEBK2002023-07-04
06971674866664BIOBASER1:60mL×2 R2:20mL×22023-07-22
06971674866671BIOBASER1:18mL×4 R2:6mL×42023-07-22
06971674866688BIOBASER1:18mL×1 R2:6mL×12023-07-22
06971674867920BIOBASECalibrator: 1mL×12023-07-22
06971674868255BIOBASEControl: 1mL×12023-07-22
06971674866190BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866206BIOBASER1:40mL×2 R2:20mL×22023-07-22
06971674866213BIOBASER1:20mL×4 R2:10mL×42023-07-22
06971674866220BIOBASER1:20mL×1 R2:10mL×12023-07-22
06971674866237BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866244BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866251BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674868231BIOBASEControl:1mL×12023-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740223724AlinityAbbott GmbHJJE2026-09-04
00380740225575ARCHITECTABBOTT LABORATORIESJJE2026-08-22
00810053950074NOVEOS Sesame Seed, Sesamum indicumHYCOR BIOMEDICAL LLCJJE2026-07-29
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
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