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CPR - Anti-A Monoclonal

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112 views3 pages

CPR - Anti-A Monoclonal

Uploaded by

D. Tomas
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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FDA.

2O2O113JIUU EVYTFU
Republic of the Philippines
Department ofHealth
FOOD AND DRUG ADMINISTRATION
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Civic Drive, Filinvest Corporate Cit_v, Alabang, lVfuntir"ilupr {.lily

Registration Status RENEWAL


FDA Registration No IVDR-O04O5
Classification

CERTIFICATE OF PRODUCT REGISTRATION


Pursuant to the provisions of Republic Act (R.A.) No. 3720 as amended, known as the Foods. Drugs. Device and
Cosmetics Act, the product more particularly described hereunder has been found to conform with the standards and have
complied with the rules and regulations governing the registration of diagnostic reagents.

Name of Product ERYCLONE@ ANTI-A MONOCLONAL


Code: 10110010

Manufacturer Tulip Diagnostics (P) Ltd. - India

Trader

Importer Biosite Medical Instruments Inc. - 512-A Manga St., Juna Subdivision, Matina Crossing 74-A,
Talomo District, Davao City, Davao del Sur
Distributor Biosite Medical Instruments Inc. - 512-A Manga St,, Juna Subdivision, Nlatina Crossing 74-A,
Talomo District, Davao City, Davao del Sur
Approved Use Intended use for the identification of "A" Antigen on human erythrocytes used in slide/tube.

Claimed Shelf-I-ife : 24 months


Storage Condition : 2-30"C
Packaging : l0ml/vial

This registration shall be valid for 5 years and shall expire on 5 July 2025 subject to the conditions listed on the
reverse side.

No change in the information, labelling and commercial presentation of this product shall be made during the
effectivity of this registration without approval of this Office.

'Ihis registration is subject to suspension, cancellation or recall should violation of any provisions of R.A. 3720, as
amended, andJor regulations issued thereunder involving the product be committed.

Witness My Hand and Seal of this Office, this 24th day of July, 2020.

BY AUTHORT|Y OF THE DIRECTOR GENERAL

o C
IV

DTN :20200213104310
O.R. No :1246754
Amount :P 5,050.00
Date Issued :13 February 2020
/kccp

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"',
i; I rDA-0471576
MANDATORY REQUIREMENT :

1. This product must be available only in drugstores, hospitals and other legal outlets.
2. The labelling of each device must state:
a) The date (montUyear) within which to use said device, whenever applicable.
b) The lot or batch number, whenever applicable.
c) Product registration number
d) Name and address of local distributor/importer.
SPECIAI CONDITION

Providsd that nothing in the registration of the product herein granted shall be interpreted or construed as an endorsement
or representation by FDA, that Registrant has the right privilege to the use of the name or brand so registered; Registrant
hereby agree and affirm to indemnify andlor hold FDA free and harmless against any and all third-party claims on
infringement of patent, trademark or industrial design rights arising from the registration of the product(s) listed on the
other side hereof.

Note: Eftectivity Date: September 20 l8 - March 202 I

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Next Review Date: September 202 I

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