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1
April 30, 2010 Approval Letter - Abbott Prism Chagas

... Our STN: BL 125361/0 Abbott Laboratories Attention: Ms. Susan Sanborn Diagnostics Division, D-49C/AP6C-2 100 Abbott Park Road Abbott Park, IL 60064-6092. ...

Center for Biologics Evaluation and Research (CBER)

2
Abbott Prism Chagas

... Resources for You. Trypanosoma cruzi (T. cruzi) (Anti-T. cruzi Assay); Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases. -. ...

Center for Biologics Evaluation and Research (CBER)

3
ABBOTT PRISM HBcore

... ABBOTT PRISM HBcore. Proper Name: Hepatitis B Virus Core Antigen (E.coli, Recombinant) Tradename: ABBOTT PRISM HBcore Manufacturer ...

Center for Biologics Evaluation and Research (CBER)

4
PRODUCT CORRECTION: ABBOTT PRISM Reaction Trays

... time (DT) error codes when using ABBOTT PRISM HBsAg (List Number 06D19) and ABBOTT PRISM HIV O Plus (List Number 03L68) assays and the ABBOTT PRISM Reaction ...

Center for Biologics Evaluation and Research (CBER)

5
Abbott Prism Positive Run Control Kit - label

Page 1. 1 ABBOTT PRISM� Positive Run Control Kit List No. 3E60-11 34-3827/R7 ABBOTT PRISM Positive Run Control Kit Customer Service ...

Center for Biologics Evaluation and Research (CBER)

6
ABBOTT PRISM HBsAg; ABBOTT PRISM HBsAg Confirmatory

... Proper Name: Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM); Antibody to Hepatitis B Surface Antigen (Human) Tradename: ABBOTT PRISM HBsAg ...

Center for Biologics Evaluation and Research (CBER)

7
Abbott Prism Run Control Kit - label

Page 1. ABBOTT PRISM Run Control Kit 1 ABBOTT LABORATORIES List No. 3E60-10 Diagnostics Division Printed in USA Abbott Park, Illinois 60064 ...

Center for Biologics Evaluation and Research (CBER)

8
Summary Basis of Approval: Hepatitis C Virus Encoded ...

Page 1. ABBOTT PRISM � HCV Summary of Basis for Approval Product Trade Name(s) ABBOTT PRISM � HCV Proper ...

Center for Biologics Evaluation and Research (CBER)

9
ABBOTT PRISM HTLV-I/HTLV-II

The ABBOTT PRISM HTLV-I/HTLV-II assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to ...

Center for Biologics Evaluation and Research (CBER)

10
Recall of Abbott Prism HIV O Plus

... REASON: Abbott has seen an increase in customer complaints for calibration failures when PRISM-HIV-1 Group O Positive Assay Control (2) (Symbol: OPC) is out of ...

Center for Biologics Evaluation and Research (CBER)

11
July 18, 2006 Approval Letter - ABBOTT PRISM HBsAg; ABBOTT PRISM ...

... We have approved your biologics license application for Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM) and Antibody to Hepatitis B Surface ...

Center for Biologics Evaluation and Research (CBER)

12
July 11, 2007 Approval Letter - Abbott PRISM HCV

... July 11, 2007. Our STN: BL 103762/0. Abbott Laboratories Attention: Susan Sanborn D-49C, AP6C/2 100 Abbott Park Road Chicago, IL 60064. Dear Ms. Sanborn: ...

Center for Biologics Evaluation and Research (CBER)

13
Abbot Prism Chagas Package Insert

... 7 specimens with elevated total bilirubin did not become ... Do not use specimens with obvious gross hemolysis. ... A test result that is negative does not exclude ...

Center for Biologics Evaluation and Research (CBER)

14
Abbott Prism Positive Run Control Kit - label

... Customer Service United States: 1-877-4ABBOTT ... in accordance with local, state, and federal regulations.7,8 ... BIBLIOGRAPHY 1. US Department of Labor, Occupational ...

Center for Biologics Evaluation and Research (CBER)

15
September 18, 2009 Approval Letter - ABBOTT PRISM HIV O ...

... BLA) for Human Immunodeficiency Virus Types 1 and 2 (E. coli, B. megaterium, Recombinant) Antigen and Synthetic Peptide effective this date. ...

Center for Biologics Evaluation and Research (CBER)

16
Hepatitis C Virus Encoded Antigens (Recombinant c100-3 ...

... signal is generated by addition of an alkaline hydrogen peroxide solution. ... to the ABBOTT PRISM Operations Manual, Section 3. REAGENTS NOTE ...

Center for Biologics Evaluation and Research (CBER)

17
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal ...

... by your firm as well as the one found on your website for the ABBOTT PRISM HBcore promote the indication, sample types, reactivity and sensitivity ...

Center for Biologics Evaluation and Research (CBER)

18
Antibody to Hepatitis B Surface Antigen (Human); ABBOTT PRISM ...

... These azides may explode upon percussion, such as hammering. ... Solutions required for instrument cleaning and maintenance are described in detail in the ...

Center for Biologics Evaluation and Research (CBER)

19
Abbott Prism Run Control Kit - label

... Sodium azide has been reported to form lead or copper azide in laboratory plumbing. These azides may explode upon percussion, such as hammering. ...

Center for Biologics Evaluation and Research (CBER)

20
ABBOTT PRISM HTLV-I/HTLV-II Package Insert

... Avoid microbial and chemical contamination of samples, reagents, and equipment. ... Hjelle B, Mills R, Swenson S, et al. ...

Center for Biologics Evaluation and Research (CBER)

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21
BioLife Plasma Services Experience with HBV NAT Testing

... Genetic Systems TM. 5,435,228, 27, 1 in 232,451. Abbott PRISM TM. 10,222,462, 8, 1 in 1,277,808. Abbott PRISM has reduced the NAT only yield by 5.5-fold. 5. ...

Center for Biologics Evaluation and Research (CBER)

22
January 16, 2008 Approval Letter - ABBOTT PRISM HTLV-1/HTLV-II

... of release from the Director, Center for Biologics Evaluation and Research (CBER). ... testing, packaging or labeling of Human T-Lymphotropic Virus Types I and II ...

Center for Biologics Evaluation and Research (CBER)

23
Hepatitis B Virus Core Antigen (E.coli, Recombinant) ABBOTT PRISM ...

... No. PLA# 98-0297 and ELA# 98-0365) ... off the blood cell, on the blood cell and on ... triglycerides, bilirubin, hemoglobin, protein and red blood cells), 4) assay ...

Center for Biologics Evaluation and Research (CBER)

24
ABBOTT PRISM@ HBsAg

... Confinnatory, BL 103766 Ver 1.1 Page 3. d. 3 Bottles (l0.4 mL each) Positive Calibrator (Human). Recalcified, inactivated plasma ...

Center for Biologics Evaluation and Research (CBER)

25
ABBOTT PRISM HTLV-I/HTLV-II Package Insert

... Virus Types I and II ... in specific immunoassays.65,66 Tests based on reactivities to HTLV-I and HTLV-II type specific proteins may enable viral typing. ...

Center for Biologics Evaluation and Research (CBER)

26
ABBOTT PRISM HIV O Plus

... For the detection of antibodies to HIV-1 (anti-HIV-1) Groups M and O and/or antibodies to HIV-2 (anti-HIV-2) in human serum and plasma ...

Center for Biologics Evaluation and Research (CBER)

27
Evaluation of Three Commercial Enzyme-Linked Immunosorbent Assays for Diagnosis of Chagas� Disease
1998-09-01

Chagas� disease is a common cause of morbidity in Latin American countries. In Brazil, naturally occurring transmission of its etiologic agent, Trypanosoma cruzi, has been almost completely abolished through effective control programs aimed at the triatomid insect vector. Thus, transfusion of blood from infected donors has become the major route for contracting ...

PubMed Central

28
Kongenitale Chagas. Einfluss einer Trypanosoma Cruzi ...
1971-04-01

... Descriptors : *CHAGAS DISEASE, *GENETICS, *EMBRYOLOGY, TRYPANOSOMA, TRYPANOSOMIASIS, INFECTIOUS DISEASES, PLACENTA ...

DTIC Science & Technology

29
Chagas Disease

... triatomine (reduviid) bug. Chagas disease is common in South America, Central America and Mexico, the primary home of ...

MedlinePLUS

30
Prism Ground Experiment.
1995-03-01

... Title : Prism Ground Experiment. ... Abstract : The 3-D Imaging performance of the PRISM Demonstration System is reported. ...

DTIC Science & Technology

31
PRISM Validation
1994-06-13

... Title : PRISM Validation. ... At distances beyond the decorrelation length, PRISM performs as well as ICED and other climatological models. ...

DTIC Science & Technology

32
Industrial Advisory Board
2011-06-23

'95-'96 Roger Gordon Industrial Advisory Board Abbott Laboratories Dr. Jonathan Miller Principal Scientist Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064...

Science.gov Websites

33
Negligible prevalence of antibodies against Trypanosoma cruzi among blood donors in the southeastern United States.
1997-11-01

Trypanosoma cruzi, a hemoflagellate, causes Chagas' disease and is endemic throughout Latin America. Increasing Latin American immigration to the United States has enhanced concern about transmission of Chagas' disease by infected donor blood. The insect vector and parasites also have been found in the southeastern United States. Autochthonous infection of ...

PubMed

34
Chagas Disease: Detailed FAQs

... Back To Top In what parts of the world is Chagas disease found? People who have Chagas disease can be found anywhere in the world. However, vectorborne transmission is confined to the Americas, ...

MedlinePLUS

36
Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime ...

... Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit. Proper ...

Center for Biologics Evaluation and Research (CBER)

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