FDA.reportPublic FDA data

Syva® Emit® II Plus Buprenorphine Assay

Primary DI
00630414601113
Brand
Syva® Emit® II Plus Buprenorphine Assay
Company
Siemens Healthcare Diagnostics Inc.
Model
10720047
Catalog number
9S029UL
Device description
Syva® Emit® II Plus Buprenorphine Assay - 115 mL kit
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DJGENZYME IMMUNOASSAY, OPIATES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150606000
K221605000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150606000Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control PositiveSiemens Healthcare Diagnostics, Inc.2015-10-23DJG
K221605000Emit® II Plus Buprenorphine AssaySiemens Healthcare Diagnostics, Inc.2023-07-25DJG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414601113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414601113006304146011136304146011130630414601113

GMDN Terms#

Term, Definition table
TermDefinition
Buprenorphine IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of buprenorphine in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-8994XX@XX.XX
+1(800)227-8994CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
Device count
1
Lot or batch
true
Expiration date on label
true

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