FDA.report

Lead Level 1

Primary DI
B800933115
Brand
Lead Level 1
Company
UTAK LABORATORIES, INC.
Model
93311
Catalog number
93311
Device description
Lead Level 1
Published
2020-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DIFDrug Mixture Control Materials

Product Code Classifications

CodeDeviceSpecialtyClass
DIFDrug Mixture Control MaterialsClinical Toxicology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B800933115PackageHIBCC5In Commercial Distribution
B800933110PrimaryHIBCC0

GMDN Terms

TermDefinition
Lead 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 lead in a clinical specimen.

Device Sizes

TypeValueUnit
Total Volume3Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
888-882-5522welovecontrol@utak.com

Regulatory Flags

DUNS number
092519016
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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

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B800DAULOWV43MLUIPM5 DRUGS OF ABUSE LOW V4DAU LOW V4 3ML U IPMDAU LOW V4 3ML U IPM2026-02-25
B800DAUMIDV43MLUIPM0DRUGS OF ABUSE MID V4DAU MID V4 3ML U IPMDAU MID V4 3ML U IPM2026-02-25
B800ETH177WBFOSBI5ETHANOL 76 MG/DLETH 76 WB F OSBIETH 76 WB F OSBI2026-02-23
B800ETH76WBFOSBI5ETHANOL 76 MG/DLETH 76 WB F OSBIETH 76 WB F OSBI2026-02-23
B800ANTIF2SQD5ANTIFUNGALS LEVEL 2ANTIF 2 S QDANTIF 2 S QD2026-02-06
B800ANLCCALMFFCCO5 ANLC CALANLC CAL M F FCCOANLC CAL M F FCCO2026-02-05
B800CONTROL1V2SSH5MIXED CONTROL LEVEL 1 V2CONTROL 1 V2 S SHCONTROL 1 V2 S SH2026-02-05
B800CONTROL2V2SSH0MIXED CONTROL LEVEL 2 V2CONTROL 2 V2 S SHCONTROL 2 V2 S SH2026-02-05
B800DAUCONT1V2FRX5DAU CONTROL LEVEL 1 V2DAU CONT 1 V2 F RXDAU CONT 1 V2 F RX2026-02-05
B800DAUCONT2V2FRX0DAU CONTROL LEVEL 2 V2DAU CONT 2 V2 F RXDAU CONT 2 V2 F RX2026-02-05
B800EIACAL2V2UFRX5 EIA CAL LEVEL 2 V2EIA CAL 2 V2 U F RXEIA CAL 2 V2 U F RX2026-02-05
B800EIACALLEVEL1V25 EIA CAL LEVEL 1 V2EIA CAL 1 V2 U F RXEIA CAL 1 V2 U F RX2026-02-05
B800EIANEGV2UFRX5 EIA NEG CAL V2EIA NEG V2 U F RXEIA NEG V2 U F RX2026-02-05
B800MET1V2WBQD5METALS LEVEL 1 V2MET 1 V2 WB QDMET 1 V2 WB QD2026-02-02
B800MET2V2WBQD5METALS LEVEL 2 V2MET 2 V2 WB QDMET 2 V2 WB QD2026-02-02
B800MET3V2WBQD5METALS LEVEL 3 V2MET 3 V2 WB QDMET 3 V2 WB QD2026-02-02
B800ACETAHIGHV2UADX5ACETAMINOPHEN PLUS HIGH V2ACETA+ HIGH V2 U ADXACETA+ HIGH V2 U ADX2026-01-16
B800ACETALOWV2UADX5ACETAMINOPHEN PLUS LOW V2ACETA+ LOW V2 U ADXACETA+ LOW V2 U ADX2026-01-16

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