FDA.reportPublic FDA data

Hydrocodone 100 Control Set

Primary DI
00850624008117
Brand
Hydrocodone 100 Control Set
Company
LIN-ZHI INTERNATIONAL, INC.
Model
08304742190
Catalog number
08304742190
Device description
HYD 100 Negative Control 75 ng/mL (2 x 15 mL), HYD 100 Positive Control 125 ng/mL (2 x 15 mL).
Published
2018-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LASDrug Specific Control Materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LASDrug Specific Control MaterialsClinical Toxicology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850624008117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850624008117008506240081178506240081170850624008117

GMDN Terms#

Term, Definition table
TermDefinition
Opiate/opiate metabolite IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of opiate and/or opiate metabolites in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
840839190
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850624008643Fentanyl II Enzyme Immunoassay10427531190104275311902025-11-17
00850624008636Fentanyl Control Set10426667190104266671902025-06-06
B07605700Fentanyl II Enzyme Immunoassay057005702022-07-22
B07605710Fentanyl II Enzyme Immunoassay057105712022-07-22
B07604100LZI Tramadol Enzyme Immunoassay041004102022-05-01
B07604110LZI Tramadol Enzyme Immunoassay041104112022-05-01
B07604120LZI Tramadol Low Calibrator041204122022-05-01
B07604130LZI Tramadol Cutoff Calibrator041304132022-05-01
B07604140LZI Tramadol Intermediate Calibrator041404142022-05-01
B07604150LZI Tramadol High Calibrator041504152022-05-01
B07604170LZI Tramadol Level 1 Control041704172022-05-01
B07604180LZI Tramadol Level 2 Control041804182022-05-01
B07605200LZI Cotinine II Enzyme Immunoassay052005202022-04-22
B07605210LZI Cotinine II Enzyme Immunoassay052105212022-04-22
B07605220LZI Cotinine II Low Calibrator052205222022-04-22
B07605230LZI Cotinine II Cutoff Calibrator052305232022-04-22
B07605240LZI Cotinine II Intermediate Calibrator052405242022-04-22
B07605250LZI Cotinine II High Calibrator052505252022-04-22
B07605270LZI Cotinine II Level 1 Control052705272022-04-22
B07605280LZI Cotinine II Level 2 Control052805282022-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B800DAU2V2ID5 DRUGS OF ABUSE LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-03-03
B800DAUHIGHV43MLUIPM0DRUGS OF ABUSE HIGH V4UTAK LABORATORIES, INC.LAS2026-02-25
B800DAULOWV43MLUIPM5 DRUGS OF ABUSE LOW V4UTAK LABORATORIES, INC.LAS2026-02-25
B800DAUMIDV43MLUIPM0DRUGS OF ABUSE MID V4UTAK LABORATORIES, INC.LAS2026-02-25
B800ETH177WBFOSBI5ETHANOL 76 MG/DLUTAK LABORATORIES, INC.LAS2026-02-23
B800ETH76WBFOSBI5ETHANOL 76 MG/DLUTAK LABORATORIES, INC.LAS2026-02-23
B800ANTIF2SQD5ANTIFUNGALS LEVEL 2UTAK LABORATORIES, INC.LAS2026-02-06
B800ANLCCALMFFCCO5 ANLC CALUTAK LABORATORIES, INC.LAS2026-02-05
B800CONTROL1V2SSH5MIXED CONTROL LEVEL 1 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800CONTROL2V2SSH0MIXED CONTROL LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800DAUCONT1V2FRX5DAU CONTROL LEVEL 1 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800DAUCONT2V2FRX0DAU CONTROL LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800EIACAL2V2UFRX5 EIA CAL LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800EIACALLEVEL1V25 EIA CAL LEVEL 1 V2UTAK LABORATORIES, INC.LAS2026-02-05
B800EIANEGV2UFRX5 EIA NEG CAL V2UTAK LABORATORIES, INC.LAS2026-02-05
B800MET1V2WBQD5METALS LEVEL 1 V2UTAK LABORATORIES, INC.LAS2026-02-02
B800MET2V2WBQD5METALS LEVEL 2 V2UTAK LABORATORIES, INC.LAS2026-02-02
B800MET3V2WBQD5METALS LEVEL 3 V2UTAK LABORATORIES, INC.LAS2026-02-02
B800ACETAHIGHV2UADX5ACETAMINOPHEN PLUS HIGH V2UTAK LABORATORIES, INC.LAS2026-01-16
B800ACETALOWV2UADX5ACETAMINOPHEN PLUS LOW V2UTAK LABORATORIES, INC.LAS2026-01-16
B800MOR225UKP5MORPHINE 225 NG/MLUTAK LABORATORIES, INC.LAS2026-01-16
B800AMPH60V2WBCP5AMPH PLUS 60 NG/ML V2UTAK LABORATORIES, INC.LAS2026-01-13
B800DAUL3UFVMCI5 DRUGS OF ABUSE LEVEL 3UTAK LABORATORIES, INC.LAS2026-01-13
B800FENTUFODX5 FENTANYL PLUSUTAK LABORATORIES, INC.LAS2026-01-06
00812101031667ARK™ Ketamine II Control (25/75)ARK DIAGNOSTICS INCLAS2025-12-27
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B800AMPQC1URIH5AMPHETAMINE LEVEL 1UTAK LABORATORIES, INC.LAS2025-12-15
B800AMPQC2URIH5AMPHETAMINE LEVEL 2UTAK LABORATORIES, INC.LAS2025-12-15
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