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FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Ultrio Plus, HIV-1 D-Probes
Not in Commercial Distribution
- 15420045500464 ()
302571
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Ultrio Plus 5K
Not in Commercial Distribution
- 15420045500457 ()
302574
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Ultrio Plus 5K
Not in Commercial Distribution
- 15420045500440 ()
302574
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Ultrio Plus 5K
Not in Commercial Distribution
- 15420045500433 ()
302574
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Ultrio Plus 5K
Not in Commercial Distribution
- 15420045500426 ()
302574
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Ultrio Plus 5K
Not in Commercial Distribution
- 15420045500419 ()
302574
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Ultrio Plus 1K
Not in Commercial Distribution
- 15420045500402 ()
302573
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Ultrio Plus 1K
Not in Commercial Distribution
- 15420045500396 ()
302573
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Ultrio Plus 1K
Not in Commercial Distribution
- 15420045500389 ()
302573
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
FDA Product Code, Supplement Authorization and FDA Listing Number are not required for BLA products.
Hologic, Inc.
Ultrio Plus 1K
Not in Commercial Distribution
- 15420045500372 ()
302573
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
320 P37,SY,2L,2LD,TV & LT COM TIED,STKR
CURBELL MEDICAL PRODUCTS, INC.
3001-991-144
In Commercial Distribution
- 00840828100847 ()
229
- Electrical mains power extension cable
No Description
Roche Diagnostics GmbH
07000979190
In Commercial Distribution
- 00875197004885 ()
07000979190
- Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Diagnostics GmbH
06998836190
In Commercial Distribution
- 00875197004717 ()
06998836190
- HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
2
In Commercial Distribution
- 00875197002706 ()
05027012190
- Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
03587797190
In Commercial Distribution
- 00875197002034 ()
03587797190
- Buffered wash solution IVD
No Description
Roche Molecular Systems, Inc.
03577163190
In Commercial Distribution
- 00875197002003 ()
03577163190
- Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
09040820190
In Commercial Distribution
- 00875197006414 ()
09040820190
- Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
28127387001
In Commercial Distribution
- 04015630936557 ()
28127387001
- Nucleic acid sample preparation instrument IVD
No Description
Roche Molecular Systems, Inc.
03502295001
In Commercial Distribution
- 04038377020556 ()
03502295001
- Nucleic acid extraction/isolation kit IVD
Aptima® HBV Quant Assay Target Enhancer Reagent.
Hologic, Inc.
KIT, TER, HBV, VL, 100T, US IVD
In Commercial Distribution
- 15420045506770 ()
PRD-04081
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, reagent
The Aptima® HBV Quant Assay is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA in human plasma and serum on the fully automated Panther® system.
Hologic, Inc.
KIT, MAIN ASSAY, HBV, VL, 100T, US IVD
In Commercial Distribution
- 15420045506749 ()
ASY-10269
- Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Alinity m HBV Application Specification File
ABBOTT MOLECULAR INC.
08N47-03B
In Commercial Distribution
- 00884999050808 ()
08N47-03B
- Laboratory instrument/analyser application software IVD
Alinity m HBV Application Specification File
ABBOTT MOLECULAR INC.
08N47-03A
In Commercial Distribution
- 00884999048645 ()
08N47-03A
- Laboratory instrument/analyser application software IVD
Alinity m HBV AMP Kit
ABBOTT MOLECULAR INC.
08N47-095
In Commercial Distribution
- 00884999047754 ()
08N47-095
- Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Abbott RealTime HBV m2000 System Combined Application CD-ROM
ABBOTT MOLECULAR INC.
02N43-004
In Commercial Distribution
- 00884999042667 ()
02N43-004
- Laboratory instrument/analyser application software IVD
Abbott RealTime HBV Amplification Reagent Kit
ABBOTT MOLECULAR INC.
2N40-91
In Commercial Distribution
- 00884999038462 ()
2N40-91
- Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Abbott RealTime HBV m2000 System Combined Application CD-ROM, Version 3.0
ABBOTT MOLECULAR INC.
2N43-03
In Commercial Distribution
- 00884999037762 ()
2N43-03
- Laboratory instrument/analyser application software IVD
Abbott RealTime HBV Amplification Reagent Kit
ABBOTT MOLECULAR INC.
2N40-90
In Commercial Distribution
- 00884999003071 ()
2N40-90
- Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Microplasty Tibial Template
Left Medial
Biomet Uk Ltd
32-422854
In Commercial Distribution
- 05019279403899 ()
- B
32-422854
- Surgical implant template, reusable
Microplasty Tibial Template
Right Medial
Biomet Uk Ltd
32-422853
In Commercial Distribution
- 05019279403882 ()
- B
32-422853
- Surgical implant template, reusable