HqP CHUNG QUoC HOA Kv

oy&H,ry_L{;=yl

19422409-8

HqP CHUNG QUoC HOA Kv

BQ NGOAI GIAO

Kinh gfti cdc c0 quan hfiu quan:

TOi x6c nhfln tdi liQu dinh kdm dugc d6ng (c6c) con d6u cria BO Y t6 vd Dich 4rCon ngudi, Hqp chring qu6c Hoa Kj,vd (c6c) con d6u ndy hodn todn dfng vd tin c6y*.

*BP Ngogi giao khing chlu trdch nhiQm vi nQi dung crta fii liQu ctinh kbm. GiAychftng nhQn ndy sE khilng cti giti tr! nAu b! thtio rdi hofrc thay itili dwoi bdt c*hinh th*c ndo.

DC chtmg thgc, TOi, Michael R. Pompeo, BO truongNgopi giao dd, giao quy6n cho Trq ly Thdm tlinhd6ng ddu BQ Ngoai giao, ghi t6n t6i vA ky t6n tpithdnh ph6 Washington D.C, ngdy l9l3Z}l9.

(Con d6u cfra BQ Ngo4i giao) (dd w)BQ tru0ng Ngo4i giao

(dd w)Trq ly Thdm dinh,

BQ Ngopi giao

Lflnh sq quin nufc CQng hda Xe hQi Chfr nghiaVi$t Nam tgi New York, Hoa K)

CHTNG NHAN

Ong Nguy6n Trong Nghia, Tty vi6n Ph6i dodn d4idiQn thucrng trgc nu6c CHXHCN Viet Nam t4i NewYork li nguoi dich vi ky vdo v6n bin ndy.

New York, ngdy 5 thdng 4 ndm 2019

T6i, Nguy6n Trong Nghia, Tiy vi0n Ph6idodn d4i diQn thucrng trr,rc nu6c CHXHCNViQt Nam t4i New York cam t<i5t Aa dich dungvi chinh xdc nQi dung vdn bin ndy tir ti6ngAnh sang ti6ng ViQt

New York, ngdy 5 thdng 4 ndm 2019

Ngudi dichLflnh srp

Nguy6n Trgng Nghia

19022409-8

Ilnited States of America

DEPARTMENT OF STATE

To all to whom these presents shall come, Greetings:

I Certiff That the document hereunto annexed is under the Seal of the Department of Healthand Human Services, United States of America, and that such Seal is entitled to fuil faith and

credit.**For the contents of the annexed document, the Department assumes no responsibility

This cerlificute is not valid d it is removed or altered in any way whatsoever

ln testimony whereof, I, Michael R. Pompeo, Secretary of State ,

have hereunto caused the seal of the Deparlment of State to be

affixed and my name subscribed by the Assistant AuthenticationOfficer, of the said Department, at the city of Washington, in the

Issued pursuant to CHXIL'. State o/Sept. 15, 1789, I Stat. 68-69; 22

USC 2657: 22USC 2651a; 5 tiSC301; 28 USC 1733 et. seq.; 8 USC1443(fl; RULE 11 Federal Rules oJ

Civil Procedure.

District of Columbia, this nineteenth day of March,2Q

of State

Assibtant Authentication Officer.

Department of State

IANH SI/ QUAN CHXHCN VIET NAM TSI NEW YORI(

CONSULATE OF THE S. R' OF VIETNAM IN NEW YORK

CHT?NG NHAN / HgP PHT(P H6A LiNH SV

C ON SU LAR AU THEN N CATI O N

l.Qudcgia: VIETNAM

Gif,Y td, tii li$u niYThis Public document

2. duqc lcf b&i Ong/ i}i: rrq li; BQ Ngo4i giao Hoa K|

has been signed bY Mr./Ms'3. mans chrii danh: Trg If Thdm tlinh" ,iiio ii in, capacitv if: Assistant Authentication oficer

+. vi cJn ddu cua: BQ Ngo4i giao Hoa Kj'

and bears the seal/sumP of:

tlugc Chrtng nhin/Hqp ph{p h6a lSnh sgCertified G t

5. Tai New York, Hoa K!' 6. ngav !. - | r(.tz0tg

in New York on dote ( dd/mm/YYYY'1.

7. C"q,r-@, Hnt srquan0nGlc{Vi€tNTgNYI:,*WiContitot, o1ine s'n' of viet Nam in New York

B.s6(N"){ilffil

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Name of Manufacturer/Distributor, Address

See Attached List

(One Page)

The product(s) described above (and the manufacturing/distribution site(s) which produces/distributes it) is subjectto 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 ofAmerica at this time. The manufacturing plant(s) in which the product(s) is produced is subject to periodicinspections. The last such inspeciion showed that the plant(s), at that time, appeared to be in substantialcompliance with current good manufacturing practice requirements for the product(s) listed above.

9^._ *-7)CAPT Sean M. Boyd, MPH, USPHSDeputy Director for Regulatory AffairsOffice of ComplianceCenter for Devices and Radiological HealthU.S. Food and Drug Administration, DHHS

This certificate is vatid from February 13, 2019 to F;bruary 12,ZOZ'1.\\

lI

Uf

fficate No. 5058-2-2019

CERTIFICATE TO FOREIGN GOVERNMENT

ln order to allow the importation of United States products into foreign countries , the U.S. Food and DrugAdministration (FDA) cedifies the following information concerning the product(s)to be expofted listed below:

G

Name of Product(s)

See Attached List

(Three Pages)

.s. rs*s & *ffi#&,**${isr!5r*&1,*&

No.5058-2-2019to Foreign Government - Name of Manufacturer/Distributor Attachment Page 1 of '!

tl.$. Footi &, ),lfii..t Adi;1ili*i:r,4iioir1 ilgli:i i',1 *x |-la rx t.!?irin l\',,*n r.*liiiver li,,rring. tllll 2{tr3:1

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Name of Owner OperatorBIOTEK INSTRUMENTS. INC.100 Tigan StreetHighland ParkWinooski, VT USA 05404

Name of ManufacturerEIOTEK INSTRUMENTS, INC-

100 Tigan StHighland Park, PO Box 998Winooski, VT USA 05404

-.--END OF MANUFACTURER/D ISTRIBUTOR LIST.--.

,.€ No. 5058-2-2019,cate to Foreign Government - Name of product(s) Attachment page 1 of 3

.ne of Owner OperatorjIOTEK INSTRUMENTS, INC.

100 Tigan Street

Highland Park

Winooski, VT USA 05404

Name of ManufacturerBIOTEK INSTRUIVIENTS, INC.

100 Tigan St

Highland Park, PO Box 998

Winooski, VT USA 05404

Name of Product(s)Microplate Spectrophotometers

PowerWaverM IVD Models. RPRW (powerWave HT)EpocS', IVD Models. Epoch, EpochR, EpochH, EpochRHEpoc6', 2 IVD Models:

Epoch2, Epoch2C, Epoch2T, Epoch2TC, Epoch2NS, Epoch2TS, Epoch2TSC, Epoch2NSCMicroplate Readers

Automated Microplate Reader. ELx800 IVD Models: ELxB00, ELx800NB, ELX800UVAutomated Microplate Reader Touchscreent B00TS IVD Models:8OOTS, sOOTSI. SOOTSUV, SOOTSUVI, SOOTSNB.

Automated Microplate Reader. ELx808 lvD Models. ELx808, Elx808lU, ELxSOS|ULAXACell lrnaging Reader

LionheartrM FX IVD; LFX, LLX

Cell lmaging Multl-Mode ReadersI |-raginc Fluorescence/Absorbance/Luminescence Reader Models:Cyi3i:ci 5 IVD: CYTSV, CYT5PV, CyTsF, CYTSFA, CYTSM, CYT5MF, CYTSMFA, CYTSVF,'lv-rFA\1 CYT5MV CYT5MPV, CYTSMFV, CyTstllFAV).-.2::^3 Ii/D CYT3V. CYT3FV, CYT3MV, CYT3MFV, CYT3F, CYT3M, CYT3MFl,:a::- 1 l',.tD: CYT1FA, CYT1V, CYTIFAV.-, c: : lesi:nology Multi-Mode Microplate Readerss-, -3'gy ii-TX lvD Fluorescence/Absorbance/Luminescence Microplate Reader Models:S'A S-L S1LA. 51LF, 51LFA, SlLFTAs;rergy 2 lvD Fluorescence/Absorbance/Luminescence Microplate Reader Moders.SA SAD. SF, SFA, SFAD, SFD, SFP, SFPA, SFPAD, SFPD, SFPT, SFPTA, SFPTAD, SFPTD, SFT,SFTA. SFTAD, SFTD, SL, SLA, SLAD, SLD. SLF, SLFA, SLFAD, SLFD, SLFP. SLFPA, SLFPD,SLFPAD, SLFPT, SLFPTA, SLFPTAD, SLFPTD, SLFT, SLFTA, SLFTAD, SLFTDsynergy H'1 IVD Fluorescence/Absorbance/Luminescence Microplate Reader Models.H,1 F, H1FD, H1M, H1MD, H1MF, HlIVFD, H1FG, HlFDG, H1MG, H,lIVDG, H1MFG, HlMFDGSynergy LX IVD Filter FluorescenceiAbsorbance Microplate Reader with Touch Screen Option:SLXA. SLXF, SLXFA, SLXATS. SLXFTS, SLXFATSSynergy NEo2 lvD Fluorescence/Absorbance/Luminescence Microplate Reader Models:NEO2. NEO2M, NEO2ALPHA, NEO2MALPHA, NEO2B, NEO2MB, NEO2ALPHAB, NEO2MALPHAB, NEO2SNEO25M, NEO2SALPHA, NEO2SMALPHA, NEO2SB, NEO2SMB, NEO2SALPHAB, NEO2SMALPHABFLx800 IVD Fluorescence/Luminescence Microplate Reader Models.FLx8OOT, FLx800TB, FLx800TBl, FLxSOOTBtD

Microplate Reader Accessories.

Biocell rM quartz read vessels, and holders. 7 27 2OSj, 7 27 O 51 2, 7 3O2O3O, 4A7 23Absorbance Optical Filters: 3100xxx where xxx = 340, 405, 415,450,490, 515, 540,550, 562, 570, 580, 590, 595, 600, 620, 630 nm, 34o4xxx and xxx = 650, 690, 750 nm,and 7334xxx where xxx = 340, 405, 415, 4S0, 490, S.lO, 515, 540, 550, 562, 570, 590, 595600, 620, 630, 650, 660, 690, 750nrn.

Filter hole plugs. 2872086, 3122037 , 7082073. Empty fitter wheel. 31 105085,3112001,7080541,733200a. Fluorescence optical Filters: Tol2xxt where xxx = 205 to 299and T092xxxwheTexxx= 145 1o299, 1035255. Filterclips: 70a2075. optical Filtercubes:PNs 1035xxx where xxx = 001 to 125,1225xw where xxx = 000 to 009 or 100 to 123, and8040xxx where xxx = 501 to 584 (some may have s at end), 1325000, 1325001. Dichroic

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rr€ No. 5058-2-2019,rcate to Foreign Government - Name of product(s) Attachment page 2 of 3

,ors. 7137xxxwhen xxx = 400 to 660; 7138xxx where xxx = 121 lo 660 and 7132j21.,'139635. Opticscase 7132166. Oblectives. 1220517,122051I,122OS1g.j22o53g,1220544,1220545,1220549,1220562,1320515,1320516,1320517,1320518,1450538,1450539

oil for objectives: 02221 Annulus. 1320520, 1320521,1320526, 1320523, 1322026 (s for any)Lamps & lamp kits 3400508, 7080500, 73305135, 7330516, 3400508,1 560532, '1560553. PMT 49721 .49984. Micro Volume ptates.

Take3rM and Take3Trio. Slide kits 4690009, 4690010, 46905035, 46905045.cuvette adapter..73a2030. Alignment tool'. 1222531 j32z5oo,1322sot. Anti-vibration plate.

1220521. Firewire card/interface. 01604, 1220535. USB card. i32oo1g cell culture flask,slide or dish adapter 1222210, 1220548,222240, 1222241. 1222242, 1222246, 1322144,0 1 985. Stage insertsiadapter: 1 450527, 1 450007, 1 450008, 1 45227 5, i 65051 6. ThermatPrinter. 02434. Joystick controller. 1320003. Jig. 1222520. Liquid Dlspenser Modules.PNs 80400035, 1340001, 8040030 Injector head/tips/bracket. 1320514,1450532,1450533,1452124,8040031,8040541. Flow meters: i2i3032,1213033. Gas regulators: 1210514,1210515. Cal kit. 1210011 castank: 01503 Gas lnfusion Tubing. .1213023. OpticalTest Platesr Absorbance: PN 726055 1 . 7 260522, 7 26A522E, 7 260522M.Fluorescence: PN 1400501.

Gas Controllers PNs 1210007, '1210008, 1210012,1210013.lmage counting chamber 1322131, holder 1320016. Environmental cover. 1450523, 14s2346.Accessory Door: 156001 3.

Reader Control & Data Reduction Software.GEN5, GENsIPLUS, GENSIVD, GENsIVDIPLUS, GENSRC, GENsSECURE,GEN5SECUREIPLUS, GEN5TSE2, GEN5 Vatidation packages (5320500 and 5320502)Microplate Washers & Washer/DispensersAutomated Strip Washer: ELX50 IVD Models.

ELx508. ELx508V, E1x5012, ELx5012V, E1x5016, ELx5016V,ELx508NI. ELx508F. ELx508MF. Liquid Levet Atert: 4070035, 4070036.A,L,icmareo Strip Washer Touchscreen: 50TS IVD Models.5]TS8 5OTS8F.5OTS8M,5OTS8MF,sOTS8V,sOTS8MV,5OTS12,5OTS12V,5OTS16,5OTS,16V.,:,r: rai3c lr,,licroplate Washers.

E-;<:15 IVD h4odels. ELx405UD. ELx4O5UVD, ELx405USD, ELx4OSUVSD. ELx40SUCWD.=Lxrl5UCIiWD ELx405UCWSD, ELx405UCVWSD.if5 Toucn IVD Models 405TSHT, 405TSHTV, 405TSU, 4Osrsuv, 405TSUS, 405TSUSe,4O5TSUVS 4O5TSUVSQ,4O5TSR,4O5TSRV,4O5TSRS,4OsTSRSQ,4O5TSRVS,4O5TSRVSQ4051S lvD Models: 405LSHT, 4O5LSHTV, 405LSU, 405LSUV. 405LSUS, 405LSUSe, 405LSUVS,405LSUVSQ, 4O5LSR, 405LSRV, 4O5LSRS, 4O5LSRSQ, 405LSRVS, 405LSRVSQN,4icroplate Washer Dispenser EL406 IVD Models. 4O6pUB1, 406pU82, 4O6pUB3,406PSUB1, 406PSU82, 406PSUB3, 406PSUOLB, 4065NAOLB, 406PSUOSB, 406PSU82LB, 406PSUB2SB406PSUB1LB, 406PSUB1SB, 406PSUB3LB, 406PSU83SB, 406P4, 4065NA4, 406PSNA4Microplaie Dispensers:

lviicroFillrM IVD lviodel. AF1000,4MultiFlorM IVD Models. MF, MFp, 72|OO1O,721OOO|,721OAO7

lvlultiFlolJ FX IVD Models. MFX, MFXp, MFXW, MFXPW, MFXpR, N/FXR,I'lFXP1, lVFXP2, MFXP2R, Upgrade kit: 1260023Microplate Washer and Dispenser Accessories:Vacuum and pressure delivery systems or pumps (Dispense/waste); 1170531S, 1170s32.'i1705345 1170s35,1170533,11705545,1'1705555,1'1705s7S,1170560, 1170561,1170562,1260542,4A70078,4070077,4070572,7100541S,71005435,710058.1S,7100s82S,71007645,71007825,71007455,71007465,7100751,7100752,71007s3S,7100754,

7100757.7100758,7102034,7103024. Dispenser cassettes. 717ooxx where xx = 07 to .16 or18to24. 12600xx where xx = 15to22. Cassette calibration kit.Z17OOj7. Magnetsand adapters: 1262063,7102215,7102216,7103016, 7103017,71gOO1i. Stytus kits2812304, 4070523, 7 1 000255

Manifolds 1170A10. 1 1720465, 1260009, 1 26001 0, 1 26001 1 1 550S04S, 1550501S,1260412,1260013,'126053xSwherex=4to7,40705125,40705i35,40705195,4070531S40705325,71020685,71105335,71105495,71105505,714050857140s155,71405185,71805435,

7'180548s 7180549s, 7180552s, 7180553s, 7180560s. Botfles/caps. 4u4a,1fi3ooo,1173002,1173003, 1170031,Q6A027,1260A28.4070076,4070075,4010515,40705455,7100531.

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,ate No. 5058-2_2019lficate to Foreign Government - Name of product(s) Attachment page 3 0f 310532.7100534,7.100s35, 710542,710A544,7100556,7100s59,7100566,

71005577140511. Tubing.1263001,1263007,1263017,4070510,4070511,2.i00533, 71OOS3771 00s38, 71 1 05235, 7 1 1 0530, 71 1 05485, 7 1 1 21 86, 7 1 4A51 O, 7 1 4051 4, 7 1 40522, 7 17 OOO7,7170008' 717oOOg'7fiA020,7170021,7170022,718A541,7183002,7183006. syringehead:7140516,7190046. syringe modure: 7180006s. Reagent sw,tching rnodure. 7180028.Liquidfirters 0131O,48146,48294 4gg43.VacuumRltration, 1.170008, 1170009, l18oo2gMuffrer' 01 1 13, 4070523,4073009. Robotic extension kit: .1 170013, 7100096. Gauge: 4030551Aerosor cover: 4o7o517 Horder:721050g. carrier: 7212o42.Drain sets: 7110015,7140006.O-Ring Set. 7110027. Dispense kit:71g0010. Enviornmental cover: 1260504.

Ljquid Handling Systems/Automation.Microplate Pipefting systems:Precision XS IVD Models. pRC384iM, pRC3841Precision IVD Models: PRC384U, 1RC3A412, PRC384M, pRC384Robotics.

BioSpa 8 Automated Incubator IVD Models. BlOSpA, BIOSpAGMicroplate Stacking Systems.

BIOSTACK4, BIOSTACKNEOWHITE731 0030. BioStack integration kits:45, 46, 47,48, 49, 53, 54, 55.

iJ.3. I:0rij 11 rJrrirJ ArJfiIirIi;1lt.i1.iori"i&'J03 i''j*;r 11;rnp;i;i;^e iiyr;rii;$iirer ::lprirq i::jD l"l;Jfilii.'"j.r.., !. i rl a. iit r,l

Biostack tVD Models: BtOSTACK2WR, BtOSTACK3WR,Stacks 1230003, i230004, 1230008, 73i0008, 7310023,73100xx where xx = 12,17,23, 30, 39, 4A,41, 42,43, 44,,Also 71 10004.

Liquid Handling Accessories:Aerosol Cabrnets: 71 13003, 7113007. pipette tips. 98188 to 98195, 98204 to gg2'7,9821 3 to gg21A, 99224, 98225, gg23g.98250 to IBZST,71120gg.Al gornent kits 1410008, 1410009, 1410010,1410011, 1410A15, 14100i6.Cii,er & replacement pafts: 1 41 001 2, 141 00 13, 1 41 21, 23, 02i24, 02i 26, 4A1 46.-:,:C Handllng Control _ pipetting & Dispensing Software:iHC2 LHC2SECURE, LH2SILA (fOr ELX4O5, MUII,FIO, EL4O6 & Oth.r iNSITUMCNIS), PRCPWRV2erecjsion pcv,ier Software,7140202 Microplate Oispenser Software (MicroFill& ciher instruments), 7.100207, TlB)2)2lnterface Software (ELx405, E1406)General accessories for products:

'laoQpQ Quarification procedures: 1020512,1030542,1210512,1170522,1170543,1220514,

't26A521 1320532' 1330520 1340508, 1350206,4070530,4070566,5320500, 5320502,7080532')9A521 7090554 7100567,7110524,7110558,7130566, 7140517,7160528,7180527,15605167 -' 3A554 7 20a51 5' 7 21 051 2, 7 28052A, 7 30051 4,73'1 0s30, 7330538, 7 340543,80305.r 4,8'4A528 Test sorutions/ reagents 4693002, 4690008, 7120779,7120782,7773001,r77 3AA2. 7773A$, 777 3005, 77730.1 5, 98.1 55.Racksi pafts, tube racks. 48397, 48398, 4g3gg,7110537, 71 10538,7':1A552'7110557,720051g.7210515.

Horders. 6002a72,6002076,7110509s,71.r05495,7110561,7110564,7112059,7112097.711210g,7112110,7112111,7112117,7112124,

7 1, 1, 213A, 7 1 1 2227, 7 1 1 2233, 71 905 1 75, 7330531, 80305 1 55, 80305 1 65.Rsservoirs/Troughs. Z 1 1 00.1 5, 7 i 1 21 1 3, 7 1 1 21 22. 7 1 40006, 7 1 821 Og, 7 1 82045.3a:.cCeReader:1030008,7310017.Cab.es.71072,25034,75A53.75104,75108,75135.

Cirer accessories and spare partsPc*ver Suppties. O1ZA|, 013j7, O22BS, 02395, 76061. 76071

-.---..--END OF PRODUCT LIST-=