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Public Health Se rvice

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Food and Drug Adminis tration
10903 New Hampshire Avenue
Silver Spring. MD 20993

Certificate No. 11088-6-2017

CERTIFICATE TO FOREIGN QOYEJif'i.Mf=NT

In order to allow the importation of United States products into foreign countries , the U.S. Food and Drug
Administration (FDA) certifies the following information concerning the product(s) to be exported listed below:

Name of Products Name of Manufacturer/Distributor, Address

See Attached List See Attached List

(Three Pages) (One Page)

The product(s) described above (and the manufacturing/distribution site(s) which produces/distributes it) is subject
to the jurisdiction of the FDA under the Federal Food , Drug, and Cosmetic Act.

It is certified that the above product(s) may be marketed in, and legally exported from, the United States of
America at this time. The manufacturing plant(s) in which the product(s) is produced is subject to periodic
inspections. The last such inspection showed that the plant(s) , at that time, appeared to be in substantial
compliance with current good manufacturing practice requirements for the product(s) listed above.

~ 1'Y ~arv-
Robin W. Newman MSN EdD CPNP
Director
Office of Compliance
Center for Devices and Radiological Health
U.S. Food and Drug Administration, DHHS

This certificate is valid from June 22, 2017 to June 21, 2019.
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DEPA RTMENT OF H EALTH & H UMAN SERV ICES Public Health Service

Food and Drug Administration

10903 New Hamp shire Avenue
'"''4111(;.. Silver Spring, MD 20993

Certificate No. 11088-6-2017

Certificate to Foreign Government - Name of Manufacturer/Distributor Attachment Page 1 of 1

Name of Manufacturer
JEOL, LTD.
3-1-2 MUSASHINO,
AKISHIMA, Tokyo JAPAN 196-8558

Legal Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown , NY USA 10591

----END OF MANUFACTURER/DISTRIBUTOR LIST----

 DEPARTtvl ENT OF H EA LTH & HUMA N SERVICES Public Health Service

Food and Drug Admin istration

10903 New Hampshire Avenue
Silver Spring, MD 20993

Certificate No. 11088-6-2017

Certificate to Foreign Government - Name of Product(s) Attachment Page 1 of 3
Name of Manufacturer
JEOL, LTD.
3- 1-2 MUSASHINO,
AKISHIMA, Tokyo JAPAN 196-8558

Legal Manufacturer
Siemens Healthcare Diagnostics Inc .
511 Benedict Ave
Tarrytown, NY USA 10591

Name of Product(s)
ADV IA Chemistry Cuvette Conditioner
10311854, 00361699, B01-4179-51
ADVIA Chemistry Cuvette Wash Solution
10311853, 00683106, B01-4178-51
ADVIA Chemistry ISE Buffer
10311849, 03463190, 801-4171-51 , 10321715, 04997873
ADVIA Chemistry ISE Detergent Solution
10311851, 01 126634, B01 -4174-52
A DVIA Chemistry ISE Electrode-CL (Chloride)
10309439, 07097504, 073-0049-01
ADVIA Chemistry ISE Electrode-K (Potassium)
10309440, 06135445, 073-0050-01
A DVIA Chemistry ISE Electrode-Na (Sodium)
10309441. 03092699, 073-005 1-0 1
ADVIA Chemistry ISE Internal Solution
10311852, 09164306, 801-41 77-5 1
A DVIA Chemistry ISE Reference Electrode
10309465, 00311764, 073-0653-01 , 10309442, 02494750, 073-0052-01
A DVIA Chemistry ISE Serum Standard Set
10311 903, 00729777, 803-4175-01
A DVIA Chemistry ISE Urine Standard Set
10311904, 06242535, 803-41 76-01
ADV IA Chemistry Reagent Probe Wash 1
10311856, 094677 16, B01-4181-55
ADVIA Chemistry Reagent Probe Wash 2
1031 1857, 04007474, B01-4182-55
ADVIA Chemistry Reagent Probe Wash 3
10311 858, 08988437, B01 -4183-51
ADVIA Chemistry Lamp Coolant Additive
103209 12, 04533710, B01-4496-51
ADVIA Chemistry Systems Sample Cup
10309450, 0 1390706 073-0157-02
ADVIA 1650 Peristaltic Pump Tube
10309444, 08771802, 073-0078-02
ADVIA Chemistry White Reagent Wedge
10309456, 03765863, 073-0372-02, 10322738, 05529881 , 094-0123-01
10309457, 063971 21, 073-0373-02
ADVIA 1650/2400 Brown Reagent Wedge
10309449, 08313370, 073-0152-02
ADVIA 1200 System:
A nalyzer
10309735, 02475632, 094-A002-01
Keyboard (120V)
02834772. 094-A001 -01
Keyboard (220V)
09562484, 094-A001-02
Keyboard (220V)
 ..i,~1a\ 1C·1,,
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l~ ~· DEPARTMENT OF HEALTH & H UMAN SERVICES Public Health Service

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-; \._. Food and Drug Administration
"·»,,~ 1ogo3 New Hampshire Avenue
~"" "' (:, Silver Spring, MD 20993

Certificate No. 11088-6-2017

Certificate to Foreign Government - Name of Product(s) Attachment Page 2 of 3
01916511, 094-A001-03
Keyboard (220V)
05038756, 094-A001-04
Keyboard (220V)
05436476, 094-A001-05
Keyboard (220V)
032624 11 , 094-A00 1-06
ADVIA 1650 System:
Analyzer
10324237, 06363413, 073-8002-01
Keyboard (220V)
104 71 11 5. 073-A001-05
Keyboard (220V)
10471 110, 073-A001-06
Keyboard (220V)
104711 11 , 073-A001-07
Keyboard (220V)
104 7111 2, 073-A001 -08
Keyboard (220V)
104 7111 3, 073-A001-09
l<eyboard (120V)
10471114. 073-A001-10
ADVIA 1800 System:
Analyzer
10315183,0141 2173, 073-A021 -01
Keyboard (120V)
10322655, 05489820, 073-A020-01
Keyboard (220V)
10337372, 06448495, 073-A020-02
Keyboard (220V)
10337373, 06448509, 073-A020-03
Keyboard (220V)
10337374 , 06448517, 073-A020-04
Keyboard (220V)
10337375, 06448525, 073-A020-05
Keyboard (220V)
10337376, 06448533, 073-A020-06
ADVIA Accessories:
Kit Workstation (220V) Printer
10484009
Language Kit
10639242
ADVIA Chemistry Method CD
10489421
Operator's Guide
10284378
ADVIA 2400 System:
Analyzer
10315769, 01 714935, 073-A0 11-02
Keyboard (220V)
10816871 , 073-A010-03
Keyboard (220V)
10816876, 073-A010-04
Keyboard (220V)
10816872. 073-A010-05
Keyboard (220V)
108 16873, 073-A010-06
Keyboard (220V)
('~~-E DEPARTMENT OFH EALTH & H UM A N SERVICllS Public Health Service

Food and Drug Adminislration

'<1,>,,. ~ 10903 New Hampshire Avenue
-!~1-.,_,u (}.
Silver Spring, MD 20993

Certificate No. 11088-6-2017

Certificate to Foreign Government - Name of Product(s) Attachment Page 3 of 3
10816874, 073-A010-07
Keyboard (120V)
10816875, 073-A010-08
ADVIA Chemistry XPT System:
Analyzer
10723034
XPT Cuvette Detergent
10718753
XPT ISE Buffer 2
1071 8754
XPT ISE Baseline Solution
10718755
XPT Probe Wash 0
10718756
--------------------------------END OF PRODUCT LIST--------------------------------------