ubio product profile 2014

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Affordable, Accurate, Accessible Diagnostics for All. Located in Cochin, Kerala State, ubio is one of the leading manufacturer of in vitro diagnostics devices in India. From its inception in the year 2008 as an Assay Development company, ubio has grown up into a full-fledged IVD manufacturer contributing largely to the human and animal health sector. The products are manufactured under ISO 13485 certified Quality Management System, in its state of the art GMP certified manufacturing facility. ubio’s new manufacturing facility commissioned in 2014, has the capacity to manufacture 200000 rapid test devices per day. This fully automated facility consists of CLASS 10000 assembly suits, under <10% RH, Automated coating, Lamination and assembly lines, Fully automated ELISA manufacturing Line, SPCE based Biosensor lines, CLASS 10000 Sterile Buffer filling facility with fully automated vial and bottle filling lines, Biosafety III culture room, cold rooms, fully equipped Quality control laboratory and R&D laboratories for Assay development, Molecular Biology and Bioengineering. HUMAN and ANIMAL HEALTH DIAGNOSTICS CONTRACT ASSAY DEVELOPMENT Low turnaround time Validated Technology platforms, Product development using technologies already commercialised by ubio. Stable Products and flexibility in optimisation. Clinical validation in actual samples. 100% confidentiality. Scaling up and pilot manufacturing facility Option for further contract manufacture Full Technology Transfer Continuous support from ubio Team. Sales and other business enquiries : +91-9562307770 Support on orders, shipments and billing : +91-9562207770 Contract Assay Development : +91 9744122269 Quality Assurance and Complaints : +91 9744022260 UBIO BIOTECHNOLOGY SYSTEMS PVT. LTD #15A, BIOTECHNOLOGY ZONE, KINFRA HITECH PARK, KALAMASSERY, COCHIN, KERALA, INDIA-683503 WEB: WWW.UBIO.IN EMAIL: CONTACT@UBIO.IN RAPID HUMAN DIAGNOSTICS RAPID VETERINARY DIAGNOSTICS CONTRACT MANUFACTURE ubio is the right manufacturing partner for you, especially if you need: Variable-volume manufacture Quick introduction of new product into the market without initial capital investment Protection for your investment against market fluctuations, obsolescence, and competition Quick scale-up to peak demand without capital investment Product List 2014 Distributed By:

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Page 1: UBIO Product Profile 2014

Affordable, Accurate, Accessible Diagnostics for All.

Located in Cochin, Kerala State, ubio is one

of the leading manufacturer of in vitro

diagnostics devices in India. From its

inception in the year 2008 as an Assay

Development company, ubio has grown up

into a full-fledged IVD manufacturer

contributing largely to the human and

animal health sector. The products are

manufactured under ISO 13485 certified

Quality Management System, in its state

of the art GMP certified manufacturing

facility.

ubio’s new manufacturing facility

commissioned in 2014, has the capacity to

manufacture 200000 rapid test devices per

day. This fully automated facility consists

of CLASS 10000 assembly suits, under <10%

RH, Automated coating, Lamination and

assembly lines, Fully automated ELISA

manufacturing Line, SPCE based Biosensor

lines, CLASS 10000 Sterile Buffer filling

facility with fully automated vial and bottle

filling lines, Biosafety III culture room, cold

rooms, fully equipped Quality control

laboratory and R&D laboratories for Assay

development, Molecular Biology and

Bioengineering.

HUMAN and ANIMAL HEALTH DIAGNOSTICS

CONTRACT ASSAY DEVELOPMENT

Low turnaround time

Validated Technology platforms,

Product development using

technologies already

commercialised by ubio.

Stable Products and flexibility in

optimisation.

Clinical validation in actual

samples.

100% confidentiality.

Scaling up and pilot

manufacturing facility

Option for further contract

manufacture

Full Technology Transfer

Continuous support from ubio

Team.

Sales and other business enquiries : +91-9562307770

Support on orders, shipments and billing : +91-9562207770

Contract Assay Development : +91 9744122269

Quality Assurance and Complaints : +91 9744022260

UBIO BIOTECHNOLOGY SYSTEMS PVT. LTD #15A, BIOTECHNOLOGY ZONE,

KINFRA HITECH PARK, KALAMASSERY,

COCHIN, KERALA, INDIA-683503

WEB: WWW.UBIO.IN

EMAIL: [email protected]

RAPID

HUMAN DIAGNOSTICS

RAPID

VETERINARY DIAGNOSTICS

CONTRACT MANUFACTURE

ubio is the right manufacturing

partner for you, especially if you

need:

Variable-volume manufacture

Quick introduction of new

product into the market

without initial capital

investment

Protection for your investment

against market fluctuations,

obsolescence, and competition

Quick scale-up to peak demand

without capital investment

Product List 2014 Distributed By:

Page 2: UBIO Product Profile 2014

TROPICAL DISEASES MALARIA PRODUCTS

Filariasis Antibody Test Lateral flow Immunoassay for anti Wuchereria bancrofti and Brugia malayi

antibodies in human blood, serum or plasma.

Leishmaniasis Antibody Tests One step Immuno qualitative detection of antibodies to members of L. donovani complex in human serum, plasma or whole blood.

Leishmaniasis Ab rK39 test This test uses rK39 antigen, and it is recommended for all geographies except East Africa.

Leishmaniasis Ab rK28 test This test uses rK28 antigen, and it is recommended for use in East African countries.

Brucella IgG Lateral flow assay for detection of IgG response of Brucella abortus, Brucella melitensis and brucella suis infection in human.

Leptospira IgM IgM lateral flow assay for Human Leptospirosis. The test is able to detect all serovars of Leptospira that causes leptospirosis in humans.

Typhoid Rapid Tests Lateral flow assays for detection of IgM and IgG antibodies specific to Salmonella enterica serovar Typhi (Salmonella Typhi) in human blood, serum or plasma. The tests use a cocktail of purified Salmonella Typhi H and O antigens. The following tests are available.

Typhoid IgG (Serum or Whole Blood)

Typhoid IgM (Serum or Whole Blood)

Typhoid IgG/IgM (Serum or Whole Blood)

Typhoid-Brucella Combo test Dengue Rapid Tests These tests detect IgG, IgM and NS1 antigens of all known four serotypes

of Dengue.

Dengue IgG/IgM

Dengue NS1 Ag Dengue NS1-IgG/IgM

Malaria Antigen Tests These tests detect Plasmodium falciparum HRP antigen and/or Plasmodium

vivax/Pan LDH antigen in Whole blood.

Malaria Pf HRP/Pan LDH Antigen test

Malaria Pf HRP/Pv LDH Antigen test

Malaria Pf HRP Antigen test

Malaria Pan LDH Antigen test

Malaria Pv LDH Antigen test Malaria Antibody Test One step immuno-chromatographic assay for detection of Pv/Pf MSP and CSP specific antibodies of all isotypes (IgA, IgG and IgM) in Human blood, serum or Plasma

ENTERIC INFECTIONS

Rota-Adeno Antigen test Rapid immuno-chromatographic assay for detection of Rota and Adeno

virus antigens in human stool in acute gastro enteritis cases.

H Pylori Antibody H.pylori test is a rapid test for the qualitative detection of antibodies of all isotypes (IgG, IgM, IgA, etc.) specific to Helicobacter pylori in human serum, plasma or whole blood

H Pylori Antigen Test H.pylori Ag test is a rapid test for the qualitative detection of Helicobacter pylori antigen in human fecal specimen.

CONTRACT MANUFACTURING PRODUCTS

The following products are available for contract manufacturing only.

C-Reactive Protein(CRP)

Thyroid Stimulating Hormone (TSH)

HIV ½ Antibody

HBsAg

HCV Antibody

HBV Ab

Syphilis

Drug of Abuse THC, TCA, K2, PCP, PPX, Oxycodone, Methadone, Morphine, MDMA, Ketamine, Methamphetamine, Barbital, Benzodiazepine, Amphetamine,

Cancer Markers PSA, CEA, AFP and CA 125

HUMAN TB ANTIGEN TESTS

MPT 64 Antigen test One step Immuno-chromatographic assy for the detection of MPT 64 Tb antigen in culture fluids and solid cultures.

TB LAM Test Mycobacterium tuberculosis and bovis specific Lipoarabinomannan antigen detection test for culture fluids. (also can be used for sputum testing)

FERTILITY HORMONES

LH test Home ovulation test for detection of Luteinising Hormone in human urine.(25mIU/ml)

hCG Home urine pregnancy test for detection of human chorionic Gonadotropins in Human urine. (10mIU/ml). Available as Card and Strips

Contract manufacturing services under OEM branding

and loan license are available.

Tests are available in default pack size of 30 tests.

Customs pack sizes also available on request.

Products are available as uncut sheets also.

HUMAN DIAGNOSTICS

UBIO BIOTECHNOLOGY SYSTEMS PVT. LTD #15A, BIOTECHNOLOGY ZONE, KINFRA HITECH PARK, KALAMASSERY,COCHIN, KERALA, INDIA-683503, WEB: WWW.UBIO.IN, EMAIL: [email protected]

Page 3: UBIO Product Profile 2014

Animal Health Diagnostics

One step Immuno-chromatographic assays

Accurate

High sensitive and good correlation with

other test method

Anywhere

- Laboratory, Farm, Clinic, Home: No

equipment needed

Simple

- One Step after collection a sample

Fast

- Reliable Result within 10 min.

Immediate

- Treatment and Management(vaccination,

quarantine) after identifying the cause

Self

- Self testing by Pet owner or Farmer

themselves

Low cost

- Time, Labor, Money saving

BOVINE/LIVESTOCK FMD NSP 3ABC Ab Rapid test

Bovine TB Ab Rapid Test

Bovine Brucella Ab Rapid test

Bovine TB-Brucella Combo Test

Bovine Anaplasma Ab Rapid test.

Rabies virus antigen test

Rota Virus Antigen test.

Brucella Antigen test

BRUCELLA SEROLOGY

Rose Bengal Plate Test Ag

Brucella RBPT Kit.

Brucella Milk Ring Test Ag

MASTITIS

CMT Reagent Kit

Lactate Dehydrogenase strip Ketosis

Beta Hydroxybutyrate strip

BOVINE PREGNANCY Bovine PAG-1 Rapid Test SWINE RAPIDS

Swine Brucella

Swine FMD NSP Ab

Classical Swine Fever

OVINE/CAPRINE TESTS

Caprine Brucella Test

PPR Ab Test

Brucella ovis Rapid test

ELISA KITS

Bovine Brucella Ab ELISA

Bovine TB ELISA

FMD NSP ELISA

FMD Typing ELISA(O, A, Asia 1)

CANINE RAPID TESTS

Canine Parvovirus Antigen Test

Canine Distemper Virus antigen Test

Canine Corona Virus antigen test

CPV-CCV Combo test

Canine Adeno virus antigen test

Canine Ehrlichia Rapid test

Canine Lyme Antibody test

Canine Leptospira IgM test

Canine Leishmania Antibody test

Canine Brucella antibody test

Canine Heartworm Antigen test.

Rota Virus Antigen Test.

Rota-Adeno Antigen Test.

Giardia Antigen test

Rabies Ag test

FELINE RAPIDS Feline Toxoplasma Antibody

test

FeLV antigen Test

FIV antibody test

FIV-FeLV Combo

Feline Parvo Rapid Test

AVIAN RAPIDS

IBD antigen test

NDV antigen test

NDV Antibody test

Marek’s Disease Ag Test

Avian Influenza Ag Test

Salmonella Pullorum Antigen

UNCUT SHEETS SECONDARY ANTIBODIES

AND CONJUGATES

MONOCLONAL/POLYCLONAL

ANTIBODIES

IVD GRADE REAGENTS

AND BUFFERS

NATIVE AND

RECOMBINANT PROTEINS

COLLOIDAL GOLD

CONJUGATES

Human Rapid Kits,

Veterinary Rapid kits

Contact us for the complete

list of available Biologicals

Anti Human IgG, IgM,

IgA, Anti Rabbit IgG,

Anti Mouse IgG, Anti

Bovine IgG,

Malaria LDH and HRP,

Dengue NS1(1, 2, 3, 4),

hCG, LH and FSH,

Veterinary Monoclonal

Antibodies, Brucella,

Anthrax, clostridium.

Bovine Serum Albumin,

Lateral flow Coating

Buffer, ELISA Plate

Stabiliser, One step TMB

substrate, Gold

conjugate Buffer, ELISA

Buffers

Brucella LPS, Salmonella

LPS, Leishmania Ag, FMD

NSP Ag, Dengue envelop

Antigen, Malaria MSP

and CSP Antigen

Unconjugated

gold(10nm-40nm),

40nm gold

conjugated

antibodies, OD 5,

OD10., Protein A

and G gold

conjugates.

DIAGNOSTICS RAW MATERIALS

VETERINARY DIAGNOSTICS

UBIO BIOTECHNOLOGY SYSTEMS PVT. LTD #15A, BIOTECHNOLOGY ZONE, KINFRA HITECH PARK, KALAMASSERY,COCHIN, KERALA, INDIA-683503, WEB: WWW.UBIO.IN, EMAIL: [email protected]