AccessGUDID - DEVICE: Premier Biotech (00812203030506)

GUDID

Device Identifier (DI) Information

Brand Name: Premier Biotech
Version or Model: PCA-10X3X-ALT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CHEMTRON BIOTECH INC

Primary DI Number: 00812203030506
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 795658603 *Terms of Use

Device Description: 10 Panel Cup, AMP500/BAR/BZO/COC150/MET500/MTD/OPI300/PCP/PPX/THC(Ox/pH/SG)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46994	Multiple drugs of abuse IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JXM	Enzyme Immunoassay, Benzodiazepine
DKZ	Enzyme Immunoassay, Amphetamine
DNK	Thin Layer Chromatography, Morphine
JXN	Enzyme Immunoassay, Propoxyphene
LCM	Enzyme Immunoassay, Phencyclidine
DIS	Enzyme Immunoassay, Barbiturate
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
DJC	Thin Layer Chromatography, Methamphetamine
LDJ	Enzyme Immunoassay, Cannabinoids
DJR	Enzyme Immunoassay, Methadone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153192	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e2573408-c97a-4423-9c3e-e8410d863d09
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: May 04, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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