当å‰ä½ç½®: 首页? 政策法规? 国家法规? FDA认å¯ä½¿ç”¨çš„检测系统和试剂监ü/a>

FDA认å¯ä½¿ç”¨çš„检测系统和试剂监ü/h1>
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核心æ示:表1:检测和鉴定食æºæ€§ç—…原èŒçš„å¾®é‡ç”ŸåŒ–å¤åˆè¯•å‰‚ç›’ 微生ç‰
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å‘布日期 æš‚æ—  生效日期 æš‚æ— 
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备注 暂无

è¡?/font>1:检测和鉴定食æºæ€§ç—…原èŒçš„å¾®é‡ç”ŸåŒ–å¤åˆè¯•å‰‚ç›’

微生�/p>

检测系统åç§?/p>

生产啅ü/p>

è‚ æ†èŒç§‘

API-20Ea

Enterotube IIa

Cobas IDA

Micro-IDb

Enterobac-

Teriaceae IIa

BioMerieux Vitek

Hazelwood,MO

Hoffmann LaRoche

Nutley, NJ

Hoffmann LaRoche

Nutley, NJ

Organon Teknika

Durham, NC

Becton Dickinson

Cockeysville, MD

æŽæ–¯ç‰¹æ°è‹ü/p>

Micro-IDc

API Lidteria

Organon Teknika

Durham, NC

BioMerieux Vitek

Hazelwood, MO

a:采纳为官方最终方法,仅用于沙门æ°èŒæ£€æµ‹ã€ü/font>

b:采纳为官方最终方法,适用于所有肠æ†èŒã€ü/font>

c:采纳为官方åˆå§‹æ–¹æ³•ã€ü/font>

è¡?/font>2微生物自动鉴宙ü/font>

商å“å称

分æžæ‰‹æ®µ

生产啅ü/p>

Automicrobic

GNIa,GPIb

Biochemical tests

生化试验

BioMerieux Vitek

Hazelwood, MO

Bactometer

Conductance

电导玆ü/p>

BioMerieux Vitek

Hazelwood, MO

ATB

Carbon assimilation

碳æºåˆ©ç”¨

BioMerieux Vitek

Hazelwood, MO

VIDAS

Automated EIAc

自动酶è”

BioMerieux Vitek

Hazelwood, MO

MIS

Fatty acid profile

脂肪酸指纸ü/p>

Microbial ID

Newark, DE

Maalthusd

Conductance

电导玆ü/p>

Radiometer America

Westlake, OH

Sensititre

Fluorogenic dnzyme

Reactions

Radiometer America

Westlake, OH

Biolog

Carbon utilization

碳利用率

Biolog

Hayward, CA

WalkAway

Biochemical

生化

Baxter Diagnostics

W. Sacramento, CA

AutoSCAN

Biochemical

生化

Baxter Diagnostics

W. Sacramento, CA

ALADIN

Biochemical

生化

Analytab Products

Plainview, NY

UniScept

AutoReader

Biochemical

生化

Analytab Products

Plainview, NY

AutoSceptor

Biochemical

生化

Becton Dickinson

Cockeysville, MD

a:食å“中沙门æ°èŒè‡ªåŠ¨æ£€æµ‹ç³»ç»Ÿï¼›AOAC采纳为åˆå§‹æ–¹æ³•ã€ü/font>

è¡?/font>3核酸æ‚交分æž

微生�/p>

商å“å称

检测手殴ü/p>

生产厂商

Campylobacter

弯曲æ†èŒ

SNAP

GENE-TRAK

Non-isotopic

éžåŒä½ç´ 

Colorimetric

比色泔ü/p>

Moloecular Biosystems

San Diego, CA

GENE-TRAK Systems

Framingham, MA

Escherichia

Coli艾æ°å¤§è‚ æ†èŒ

GENE-TRAK

Colorimetric

比色泔ü/p>

GENE-TRAK Systems

Framingham, MA

Listeria

æŽæ–¯ç‰¹æ°è‹ü/p>

GENE-TRAK

AccuProbeb

Colorimetric

比色泔ü/p>

Chemiluminescent

化学å‘光泔ü/p>

GENE-TRAK Systems

Framingham, MA

GEN-PROBE

San Diego, CA

Salmonella

沙门æ°èŒ

GENE-TRAK

GENE-TRAK

Isotopicc

åŒä½ç´Ÿü/p>

Colorimetrica

比色泔ü/p>

GENE-TRAK Systems

Framingham, MA

GENE-TRAK Systems

Framingham, MA

Staphylococcus

Aureus金黄色葡è„çƒè‹ü/font>

GENE-TRAK

Colorimetric

比色泔ü/p>

GENE-TRAK Systems

Framingham, MA

Yersinia

Enterocolitica

肠炎耶尔森æ°è‹ü/p>

GENE-TRAK

Colorimetric

比色泔ü/p>

GENE-TRAK Systems

Framingham, MA

aï¼™ü/font>AOAC地ä½ï¼šé‡‡çº³ä¸ºåˆå§‹æ–¹æ³•ã€ü/font>

b:用纯培养物鉴定ã€ü/font>

cï¼™ü/font>AOAC地ä½ï¼šé‡‡çº³ä¸ºæœ€ç»ˆæ–¹æ³•ã€ü/font>

è¡?/font>4å…疫分æž

微生物毒紟ü/p>

商å“å称

分æžæ‰‹æ®µ

生产啅ü/p>

Bacillus cereus

Diarrheal

Enterotoxin

蜡样芽肠è‚èŒ

股泻毒素

TECRA EIA

BCET-RPLA

 

RPLA

Bioenterprises

Roseville, Australia

Unipath (Oxod)

Ogdensburg, NY

Campylobacter

弯曲è‚èŒ

Campyslide

Meritec-campy

MicroScreen LA

LA

LA

RPLA

Becton Dickinson

Cockeysville, MD

Meridian Diagnostic

Cincinnati, OH

Mercia Diagnostics

Shalrord, UK

Clostridium

Perfringens

Enterotoxin

产气èšè†œæ¢­èŒè‚ æ¯’ç´Ÿü/p>

PET-RPLA

RPLA

Unipath (Oxoid)

Ogdensburg, NY

Escherichia

Coli EHECb

0157:H7

出血æ€?/font>0157ï¼™ü/font>H7大肠è‚èŒ

Petrifilm

HEC

HEC 0157

 

 

EHEC-TEK

Coline

Immuno-

blot

EIA

LA

EIA

Dipstick-

EIA

3M, St. Paul, MN

3M, Canada

London, Ontario

Unipath (Oxoid)

Ogdensburg, NY

Organon-Teknika

Durham, NC

AMPCOR

Camden, NJ

Literia

æŽæ–¯ç‰¹æ°è‹ü/p>

Listeria-TEK

TECRAc,d

Assurance

Listertest

EIA

EIA

Immunobead

Organon Teknika

Durham, NC

Bioenterprises

Roseville, Australia

BioControl Systems

Bothell, WA

Salmonella

沙门æ°èŒ

Bactigen

Spectate

Microscreen

LA

LA

LA

Wampole Labs

Cranbury, NJ

Rhone-Poulenc

Glasgow, UK

Mercia Diagnostics

Surrey, UK

è¡?/font>4å…疫分æžï¼ˆç»­è¡¨ï¼‰

微生物毒紟ü/p>

商å“å称

分æžæ‰‹æ®µ

生产啅ü/p>

 

Wellcolex

LA

Laboratoire Wellcome

Paris, France

 

Serobact

LA

LA

REMEL, Lenexa, KS

Unipath (Oxoid)

Ogdensburg, NY

 

1-2 Test

Immuno-

Diffusion

BioControl Dystems

Bothell, WA

 

PATH-STIK

Dipstick-

EIA

LUMAC, Landgraaf

The Netherlands

 

Salmonella-

TEKd,e

EIA

Organon Teknika

Durham, NC

 

TECRAc,f

EIA

Bioenterprises

Roseville, Australia

 

Unique

Dipstick-

EIA

Bioenterprises

Roseville, Australia

 

EQUATE

EIA

Binax, Portland, ME

 

BacTrace

EIA

Kirkegaard Perry

Gaithersburg, MD

 

Assurancef

ELA

BioControl Systems

Bothell, WA

å¿—è´ºæ°èŒ

Bactigen

LA

Wampole Babs

Cranbury, NJ

 

Wellcolex

LA

Laboratoire Wellcome

Paris, France

金黄色葡è„çƒè‹ü/p>

Staphylo-

Slide

LA

Becton Dickinson

Cockeysville, MD

金黄色葡è„çƒèŒè‚ æ¯’ç´ 

STE-RPLA

RPIA

Unipath (Oxoid)

Ogdensburg, NY

 

TECRAc,d

EIA

Bioenterprises

Roseville, Australia

 

SET-EIA

EIA

Toxin Technology

Madison, WI

   

ELA

Transia

Lyon, France

Vibrio

Cholerae

Enterotoxin

霉肠è‚èŒè‚ æ¯’ç´Ÿü/p>

VET-RPLAg RPLA

Unipath (Oxois)

Ogdensburg, NY

 

a:缩写:EIAé…¶å…疫分æžï¼›RPLA,å相被动乳胶å‡é›†ã€ü/font>

LA,乳胶å‡é›†ã€ü/font>

b:溶血性大肠è‚èŒã€ü/font>

c:也适用äºü/font>Bioproã€ü/font>

dï¼™ü/font>AOAC地ä½ï¼šé‡‡çº³ä¸ºåˆå§‹æ–¹æ³•ã€ü/font>

e:两ç§ä¸åŒå¢žå¼ºé…¸å…疫分æžçš„方法:检测所有食å“或低水份食å“中的沙门æ°èŒã€ü/font>

fï¼™ü/font>AOAC地ä½ï¼šé‡‡çº³ä¸ºæœ€ç»ˆæ–¹æ³•ã€ü/font>

g:也å¯æ£€æµ‹å¤§è‚ è‚èŒè€çƒ­æ¯’ç´ ã€ü/font>

5其它商å“化快速检测方法和培养培ü/font>

微生�/p>

商å“å称

分æžæ‰‹æ®µ

生产啅ü/p>

Bacteria

细èŒ

Redigelb

Medium,

APC

RCR Scientific

Goshen, TN

 

Isogridb

HGMF

QA Labs

San Diego, CA

 

Enlitenc

ATP

Promega

Madison, WI

 

Petrifilmd

Dry-film

3M, St. Paul, MN

Cliform/大肠èŒç¾¤

E. coli埃希æ°å¤§è‚ æ†è‹ü/font>

Isogridb

HGMF/MUG

QA Labs

San Diego, CA

 

Petrifilmd

Dry-film

3M, St. Paul, MN

 

ColiQuike

MUG &

ONPG

Hach Company

Ames, IA

 

Colilertc

MUG &

ONPG

Environetics

Branford, CT

 

LST-MUGf

MPN-

Medium

Difco, Detroit, Mi &

Gibco, Grand Island, NY

 

Colitrak

MPN-MUG

Biocontrol Systems

Bothell, WA

 

ColiCom-

pleteb

Enzymatic

Biocontrol Systems

Bothell, WA

E. coli

大肠è‚èŒ

MUG disc

MUG

REMEL,Lenexa, KS

Salmonella

沙门æ°èŒ

Isogridd

HGMF

QA Labs

San Diego, CA

 

OSRT

Medium/

motility

Unipath (Oxoid)

Ogedensburg, NY

 

Rambach

Medium

Technogram

Paris,France

 

MUCAP

C8

Esterase

Biolife

Milano, Italy

 

XLT-4

Medium

Difco, Detroit, MT

Yersinia

åµå°”森æ°è‹ü/p>

Dye

binding

Crytal

Violet

æ´æ™¶ç´?/p>

Polysciences

Warrington, PA

a:缩写:APC,需氧èŒå¹³æ¿è®¡æ•°ï¼šü/font>HGMF,ç–水格栅滤膜;

ATP,三磷胶腺苷:ü/font>MNG+ü/font>4-甲基伞形酮ã€ü/font>

ONPG+ü/font>0-ç¡åŸºè‹?/font>005-B-D苷露糖苷ã€ü/font>

MPN,最大近似值ã€ü/font>

b:采纳为最终方法ã€ü/font>

c:应用于牛奶检测ã€ü/font>

d:采纳为åˆå§‹æ–¹æ³•ã€ü/font>

e:应用于水质分æžã€ü/font>

f:用于冷冻或冷è—食å“的大肠è‚èŒåˆ†æžï¼Œé‡‡çº³ä¸ºæœ€ç»ˆæ–¹æ³•ã€ü/font>

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